Abstract
Background:
The US Food and Drug Administration (FDA) ensures that clinical trials meet regulatory and ethical standards through inspections of researchers, also known as clinical investigators. Inspections with significant regulatory/ethical violations may result in regulatory actions, such as a warning letter or a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE). Objectives included the standardization of regulatory violation themes cited by the FDA for novel analysis of published regulatory actions rate issued by study intervention type, violation theme by intervention type, and violation theme variation between regulatory action type.
Methods:
Cross-sectional analysis of regulatory actions from October 1, 2006, to September 30, 2015, for inspections of researchers. For each FDA regulatory action, the main measure was the Code of Federal Regulations cited coded into a violation theme. Data were paired with FDA’s published researcher inspection metrics to perform fiscal year analysis.
Results:
The FDA conducted 6375 domestic inspections of researchers in 2007 to 2015: 360 had significant regulatory violations, and 194 received published regulatory actions. Since 2007, rates of significant deviations have decreased. Medical device researchers had higher rates of warning letter issuance than did biologic product researchers. In contrast, medical device researchers had lower rates of NIDPOE issuance as compared to rates of biologic or pharmaceutical researchers. Lack of researcher supervision and submission of false information were cited more frequently for NIDPOEs.
Conclusions:
Researcher compliance has significantly improved as evidenced by medical device researchers having the lowest rate of the most significant noncompliance. Disqualification is more likely to occur when researchers fail to supervise the trial or false information is submitted.
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24.Warning letter issued to
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25.Warning letter issued to
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26.Warning letter issued to
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Michael E.
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27.Warning letter issued to
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28.Warning letter issued to
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29.Warning letter issued to
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30.Warning letter issued to
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31.Warning letter issued to
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32.Warning letter issued to
Velmahos
George C.
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33.Warning letter issued to
Srinivasan
Pattanam D.
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34.Warning letter issued to
Mansour
Moussa C.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm425881.htm. March 18, 2014. Accessed April 28, 2016 .
35.Warning letter issued to
Ubani
Agnes
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm381652.htm. November 21, 2013. Accessed April 28, 2016.
36.Warning letter issued to
Alzohaili
Opada
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm406852.htm. July 7, 2014. Accessed April 28, 2016.
37.Warning letter issued to
Aqua
Keith A.
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38.Warning letter issued to
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Ruemu E.
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39.Warning letter issued to
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Stanislaw R.
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40.Warning letter issued to
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Ana J.
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41.Warning letter issued to
Samudrala
Sreedhar
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42.Warning letter issued to
Sewell
Michele A.
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43.Warning letter issued to
Weiner
Gilbert A.
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44.Warning letter issued to
Wise
John M.
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45.Warning letter issued to
Zimmerman
Ralf
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46.Warning letter issued to
Nguyen
Binh Bui
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47.Warning letter issued to
Gross
Howard M.
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48.Warning letter issued to
Michlin
Bernard A.
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49.Warning letter issued to
Taber
Louise A.
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50.Warning letter issued to
Chambers
Edward
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51.Warning letter issued to
Conti
Ralph M.
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52.Warning letter issued to
Lein
David A.
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53.NIDPOE issued to
Bigg
Daniel
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54.Warning letter issued to
Bartholomew
Bradley J.
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55.Warning letter issued to
Fobi
Mathias Al
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56.Warning letter issued to
Kagan
Richard J.
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57.Warning letter issued to
Morgan
Steven J.
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58.Warning letter issued to
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Charles D.
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59.Warning letter issued to
Ritch
Robert
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60.Warning letter issued to
Sharma
Baljit K.
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61.Warning letter issued to
Tobler
William D.
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62.Warning letter issued to
Traina
Steve M.
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63.Warning letter issued to
McInture Bridges
R.
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64.Warning letter issued to
Eles
Gustav
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65.Warning letter issued to
Janssen
Michael E.
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66.Warning letter issued to
Stroup
Steven L.
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67.Warning letter issued to
Verrer
Edward
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68.Warning letter issued to
Davis
Thomas P.
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69.NIDPOE issued to
Overlie
Paul A.
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70.Warning letter issued to
Amato
Robert J.
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71.Warning letter issued to
Herron
Jerry M.
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72.Warning letter issued to
Kim
Lawrence S.
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73.Warning letter issued to
Clinton Lawrence
E.
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74.Warning letter issued to
Linden
David
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75.Warning letter issued to
Murray
Robert Mitchell
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76.Warning letter issued to
Schworer
Philip B.
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77.Warning letter issued to
Underwood
Hollis J.C.
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78.Warning letter issued to
Vesole
David H.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076403.htm. May 30, 2007. Accessed April 25, 2016 .
79.NIDPOE issued to
Vestal
James C.
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80.NIDPOE issued to
Kapner
Jamie
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81.NIDPOE issued to
Agus
Bertrand
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82.NIDPOE issued to
Achreja
Manjeet Kaur
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83.Warning letter issued to
Miller
Michael S.
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84.NIDPOE issued to
Runels
Charles E.
Jr
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85.NIDPOE issued to
Lofgren
David Nils
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86.Warning letter issued to
Bradford
Michael
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076521.htm. October 1, 2007. Accessed April 25, 2016.
87.Warning letter issued to
Gordon
Stephen W.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048333.htm. April 21, 2008. Accessed April 25, 2016 .
88.Warning letter issued to
Hoffman
David C.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048368.htm. March 19, 2008. Accessed April 25, 2016 .
89.Warning letter issued to
Husain
Mustafa M.
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90.Warning letter issued to
Nauta
Haring J.W.
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91.Warning letter issued to
Rai
Ansaar T.
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92.Warning letter issued to
Schneider
Alan L.
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93.Warning letter issued to
Wheatley
Susan J.
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94.Warning letter issued to
White
Rodney A.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048138.htm. September 5, 2008. Accessed April 25, 2016 .
95.Warning letter issued to
Ziran
Bruce H.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048162.htm. August 27, 2008. Accessed April 25, 2016 .
96.Warning letter issued to
Adams
Mark
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048424.htm. January 23, 2008. Accessed April 25, 2016.
97.Warning letter issued to
D’Ambrosia
Robert D.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048352.htm. April 4, 2008. Accessed April 25, 2016 .
98.Warning letter issued to
Becker
Hilton
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048372.htm. March 13, 2008. Accessed April 25, 2016.
99.Warning letter issued to
Katzen
Barry T.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048408.htm. January 30, 2008. Accessed April 25, 2016 .
100.Warning letter issued to
Kollef
Marin H.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048416.htm. January 28, 2008. Accessed April 25, 2016 .
101.Warning letter issued to
Asfora
Wilson T.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048351.htm. April 7, 2008. Accessed April 25, 2016 .
102.Warning letter issued to
Hamlin
Charles
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048260.htm. June 2, 2008. Accessed April 25, 2016.
103.Warning letter issued to
Brar
Saroj
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048366.htm. March 20, 2008. Accessed April 25, 2016.
104.Warning letter issued to
Chaganti
Surendra
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076557.htm. October 26, 2007. Accessed April 25, 2016 .
105.Warning letter issued to
Corces
Arturo
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048275.htm. May 28, 2008. Accessed April 25, 2016.
106.Warning letter issued to
Gardziola
Gregory
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048144.htm. September 3, 2008. Accessed April 25, 2016 .
107.Warning letter issued to
Hsueh
Willa A.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048268.htm. May 30, 2008. Accessed April 25, 2016 .
108.Warning letter issued to
Klein
Kevin W.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048398.htm. February 13, 2008. Accessed April 25, 2016 .
109.Warning letter issued to
Mostel
Edward
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048301.htm. May 16, 2008. Accessed April 25, 2016 .
110.Warning letter issued to
Golzar
Nasim
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048320.htm. May 1, 2008. Accessed April 25, 2016.
111.Warning letter issued to
Ponugoti
Nagarjuna R.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048250.htm. June 6, 2008. Accessed April 25, 2016 .
112.Warning letter issued to
Rapoport
Alan
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2007/ucm076556.htm. October 26, 2007. Accessed April 25, 2016.
113.Warning letter issued to
Shah
Ashok
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048369.htm. March 19, 2008. Accessed April 25, 2016.
114.Warning letter issued to
Whittier
Frederick C.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048377.htm. March 6, 2008. Accessed April 25, 2016 .
115.NIDPOE issued to
Gupta
Suresh
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM143668.pdf. September 12, 2008. Accessed April 25, 2016 .
116.NIDPOE issued to
Garjian
Peggy Ann
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM143679.pdf. August 25, 2008. Accessed April 25, 2016 .
117.NIDPOE issued to
Raval
Pramod
. http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm103515.htm.pdf. February 21, 2008. Accessed April 25, 2016 .
118.NIDPOE issued to
Ericsson
Arthur Dale
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM143680.pdf. March 31, 2008. Accessed April 25, 2016 .
119.NIDPOE issued to
Guy
Matthew J.
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM143694.pdf. January 24, 2008. Accessed April 25, 2016 .
120.Warning letter issued to
Kirkwood
John M.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm183577.htm. September 15, 2009. Accessed April 26, 2016 .
121.Warning letter issued to
Kirkwood
John M.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm183577.htm. September 15, 2009. Accessed April 26, 2016 .
122.Warning letter issued to
Feins
Neil R.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm172179.htm. May 20, 2009. Accessed April 26, 2016 .
123.Warning letter issued to
Jones
Thomas K.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm172235.htm. July 1, 2009. Accessed April 26, 2016 .
124.Warning letter issued to
Lisanby
Sarah H.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048097.htm. October 6, 2008. Accessed April 26, 2016 .
125.Warning letter issued to
Perich
Larry M.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048056.htm. December 1, 2008. Accessed April 26, 2016 .
126.Warning letter issued to
Rezai
Ali R.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm175772.htm. November 13, 2008. Accessed April 26, 2016 .
127.Warning letter issued to
Saudek
Christopher D.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm167675.htm. November 13, 2008. Accessed April 26, 2016 .
128.Warning letter issued to
Phillips
Robert A.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm175774.htm. July 20, 2009. Accessed April 26, 2016 .
129.Warning letter issued to
Ringel
Richard E.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm164618.htm. May 20, 2009. Accessed April 26, 2016 .
130.Warning letter issued to
Branitz
Bruce
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm162812.htm. April 9, 2009. Accessed April 26, 2016.
131.Warning letter issued to
Brewer
George J.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm152450.htm. January 14, 2009. Accessed April 26, 2016 .
132.Warning letter issued to
Bukowski
Ronald
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm131662.htm. March 30, 2009. Accessed April 26, 2016.
133.Warning letter issued to
Chappel
Christopher
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm148352.htm. February 2, 2009. Accessed April 26, 2016.
134.Warning letter issued to
Coté
Charles J.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm132595.htm. March 2, 2009. Accessed April 26, 2016 .
135.Warning letter issued to
Desai
Virendra
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm132592.htm. March 2, 2009. Accessed April 26, 2016.
136.Warning letter issued to
Gordon
Mark F.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm170081.htm. June 26, 2009. Accessed April 26, 2016 .
137.Warning letter issued to
Harris
Barbara A.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm176373.htm. July 27, 2009. Accessed April 26, 2016 .
138.Warning letter issued to
Hijazi
Saad
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm166520.htm. May 19, 2009. Accessed April 26, 2016.
139.Warning letter issued to
Holub
Richard
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048111.htm. October 1, 2008. Accessed April 26, 2016 .
140.Warning letter issued to
Linzer
Dov
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm174744.htm. June 12, 2009. Accessed April 26, 2016 .
141.Warning letter issued to
Paulson
Daniel M.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm132588.htm. March 11, 2009. Accessed April 26, 2016 .
142.Warning letter issued to
Quinones
Manuel J.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm132590.htm. March 3, 2009. Accessed April 26, 2016 .
143.Warning letter issued to
Spirtos
Nicola
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm149280.htm. January 3, 2009. Accessed April 26, 2016 .
144.Warning letter issued to
Stewart
Lynette
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm152639.htm. January 21, 2009. Accessed April 26, 2016 .
145.Warning letter issued to
Wright
Richard A.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm148993.htm. February 18, 2009. Accessed April 26, 2016 .
146.Warning letter issued to
Zosa
Noli R.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm170029.htm. June 16, 2009. Accessed April 26, 2016 .
147.NIDPOE issued to
David Craig
Loucks,
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM180531.pdf. August 18, 2009. Accessed April 26, 2016 .
148.NIDPOE issued to Manuel Macapinlac . http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM260219.pdf. February 23, 2009. Accessed April 26, 2016 .
149.NIDPOE issued to
Marker
Howard W.
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM143608.pdf. January 29, 2009. Accessed April 26, 2016 .
150.NIDPOE issued to
Ramirez-Melendez
Ramon
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM143667.pdf. October 21, 2008. Accessed April 26, 2016 .
151.NIDPOE issued to
Zabalgoitia-Reyes
Miguel
. http://www.accessdata.fda.gov/scripts/SDA/sdDetailNavigation.cfm?sd=clinicalinvestigatorsdisqualificationproceedings&id=CD5EDDB44D65AA37E040A8C0754D57E1&rownum=5. June 8, 2009. Accessed April 26, 2016 .
152.Warning letter issued to
Nemechek
Patrick
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm219581.htm. June 28, 2010. Accessed April 26, 2016 .
153.Warning letter issued to
Toledo
Charles H.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm204871.htm. March 11, 2010. Accessed April 26, 2016 .
154.Warning letter issued to
Harlin
Stuart A.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm220637.htm. July 21, 2010. Accessed April 26, 2016 .
155.Warning letter issued to
Jenkins
Herman A.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm222764.htm. August 16, 2010. Accessed April 26, 2016 .
156.Warning letter issued to
Songer
Matthew N.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm226980.htm. August 27, 2010. Accessed April 26, 2016 .
157.Warning letter issued to
Perez-Cruet
Miguelangelo J.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm212430.htm. March 2, 2010. Accessed April 26, 2016 .
158.Warning letter issued to
Potter
Daniel A.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm197438.htm. November 2, 2009. Accessed April 26, 2016 .
159.Warning letter issued to
Pozner
Jason
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm219020.htm. June 25, 2010. Accessed April 26, 2016 .
160.Warning letter issued to
Scully
Sean
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm220864.htm. July 30, 2010. Accessed April 26, 2016 .
161.Warning letter issued to
Buettner
Craig M.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm193489.htm. November 24, 2009. Accessed April 26, 2016 .
162.Warning letter issued to
Chawla
Sant P.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm207168.htm. March 17, 2010. Accessed April 26, 2016 .
163.Warning letter issued to
Dallas
Anthony
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm190830.htm. November 9, 2009. Accessed April 26, 2016 .
164.Warning letter issued to
Deitz
Robert
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm208002.htm. April 1, 2010. Accessed April 26, 2016 .
165.Warning letter issued to
Gazda
Thomas
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm196080.htm. November 24, 2009. Accessed April 26, 2016 .
166.Warning letter issued to
McKay
Charles
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm188805.htm. October 23, 2009. Accessed April 26, 2016 .
167.Warning letter issued to
Nasr
Samya
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm199751.htm. January 28, 2010. Accessed April 26, 2016 .
168.Warning letter issued to
O’Barr
Thomas
Jr
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm228412.htm. September 30, 2010. Accessed April 26, 2016 .
169.Warning letter issued to
Picus
Joel
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm227878.htm. September 20, 2010. Accessed April 26, 2016 .
170.Warning letter issued to
Punjwani
Sohail
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm202862.htm. February 4, 2010. Accessed April 26, 2016 .
171.Warning letter issued to
Lamar Snow
L.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm228400.htm. September 29, 2010. Accessed April 26, 2016 .
172.Warning letter issued to
Summers
Timothy
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm202614.htm. February 24, 2010. Accessed April 26, 2016 .
173.Warning letter issued to
Ward
John A.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/ucm194372.htm. December 3, 2009. Accessed April 26, 2016 .
174.NIDPOE issued to
Berger
Daniel S.
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM193324.pdf. November 27, 2009. Accessed April 26, 2016 .
175.NIDPOE issued to
Eugene
Lu
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM206102.pdf. March 16, 2010. Accessed April 26, 2016 .
176.NIDPOE issued to
Pierce
Keith Jeffrey
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM206819.pdf. March 17, 2010. Accessed April 26, 2016 .
177.NIDPOE issued to
Reuben
Scott S.
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM290801.pdf. March 17, 2010. Accessed April 26, 2016 .
178.NIDPOE issued to
Saadeh
Ghandi M.
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM197032.pdf. January 4, 2010. Accessed April 26, 2016 .
179.NIDPOE issued to
Niederman
Alan
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM239218.pdf. November 1, 2010. Accessed April 27, 2016 .
180.NIDPOE issued to
Spencer
Wayne E.
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM263782.pdf. April 20, 2011. Accessed April 27, 2016 .
181.NIDPOE issued to
Berger
Michael Dean
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm279725.pdf. September 26, 2011. Accessed April 27, 2016 .
182.Warning letter issued to
Caton
John
Jr
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm271583.htm. August 26, 2011. Accessed April 27, 2016 .
183.Warning letter issued to
Cohen
Yale
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm268290.htm. August 12, 2011. Accessed April 27, 2016 .
184.Warning letter issued to
Griffin
John
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm247469.htm. March 14, 2011. Accessed April 27, 2016 .
185.Warning letter issued to
Horowitz
Jeffrey
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm248621.htm. March 12, 2011. Accessed April 27, 2016 .
186.Warning letter issued to
Bosserman
Linda D.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm264129.htm. July 19, 2011. Accessed April 27, 2016 .
187.Warning letter issued to
Lippton
Howard L.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm230909.htm. October 20, 2010. Accessed April 27, 2016 .
188.Warning letter issued to
Mancha
Vaughn H.
Jr
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm244336.htm. February 17, 2011. Accessed April 27, 2016 .
189.Warning letter issued to
Michelson
Joseph B.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm263950.htm. July 6, 2011. Accessed April 27, 2016 .
190.Warning letter issued to
Judith Ratzan
R.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm248622.htm. February 16, 2011. Accessed April 27, 2016 .
191.Warning letter issued to
Scott
David F.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm230860.htm. October 20, 2010. Accessed April 27, 2016 .
192.Warning letter issued to
Simmons
John F.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm244485.htm. February 28, 2011. Accessed April 27, 2016 .
193.Warning letter issued to
Thurmond-Anderle
Margaret E.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm245263.htm. February 25, 2011. Accessed April 27, 2016 .
194.Warning letter issued to
Zaiac
Martin
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm248222.htm. March 21, 2011. Accessed April 27, 2016 .
195.NIDPOE issued to
Candal
Francisco J.
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM250107.pdf. March 2, 2011. Accessed April 27, 2016 .
196.NIDPOE issued to
Holmes
Amy S.
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM236203.pdf. December 2, 2010. Accessed April 27, 2016 .
197.Warning letter issued to
Sanderlin
Damien B.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm313927.htm. July 27, 2012. Accessed April 27, 2016 .
198.NIDPOE issued to
Lasala
Gabriel Perez
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM296030.pdf. February 16, 2012. Accessed April 27, 2016 .
199.NIDPOE issued to
Richards
Jon
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM318307.pdf. August 28, 2012. Accessed April 27, 2016 .
200.Warning letter issued to
Malcolm
Matthew P.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm311275.htm. May 22, 2012. Accessed April 27, 2016 .
201.Warning letter issued to
Jenis
Louis G.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm294772.htm. February 14, 2012. Accessed April 27, 2016 .
202.Warning letter issued to
Hewett
John Joseph
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm378820.htm. September 5, 2012. Accessed April 27, 2016 .
203.Warning letter issued to
Makam
Satyaprakash N.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm320980.htm. December 19, 2011. Accessed April 27, 2016 .
204.Warning letter issued to
Boyce
Steven W.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm325894.htm. September 28, 2012. Accessed April 27, 2016 .
205.Warning letter issued to
Diaz
Leslie E.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm279184.htm. November 4, 2011. Accessed April 27, 2016 .
206.Warning letter issued to
Houser
Elizabeth E.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm306201.htm. May 12, 2012. Accessed April 27, 2016 .
207.Warning letter issued to
Teasley
Laura A.
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm277338.htm. October 14, 2011. Accessed April 27, 2016 .
208.Warning letter issued to
Tuller
Betty
. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm291509.htm. November 21, 2011. Accessed April 27, 2016 .
209.NIDPOE issued to
Mendolia
Thomas Francis
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM289180.pdf. November 22, 2011. Accessed April 27, 2016 .
210.NIDPOE issued to
Alexander
Elmore
. http://www.fda.gov/downloads/ICECI/EnforcementActions/WarningLetters/UCM295581.pdf. January 27, 2012. Accessed April 27, 2016 .
211.NIDPOE issued to
Corbett
Bernard A
III
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm410347.pdf. July 16, 2014. Accessed April 28, 2016 .
212.NIDPOE issued to
Calenoff
Emanuel
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm423299. September 25, 2014. Accessed April 28, 2016 .
213.NIDPOE issued to
Kumar
Anil
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm402312.pdf. May 2, 2014. Accessed April 28, 2016 .
214.NIDPOE issued to
Patel
Manoj K.
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM400178.pdf. April 30, 2014. Accessed April 28, 2016 .
215.NIDPOE issued to
Papilion
John D.
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm402309.pdf. April 11, 2014. Accessed April 28, 2016 .
216.NIDPOE issued to
Bilezikian
John P.
. http://www.fda.gov/downloads/regulatoryinformation/foi/electronicreadingroom/ucm434135.pdf. January 12, 2015. Accessed April 29, 2016 .
217.NIDPOE issued to
Marquez
Farid
. http://www.fda.gov/downloads/RegulatoryInformation/FOI/ElectronicReadingRoom/UCM459610.pdf. June 26, 2015. Accessed April 29, 2016 .