FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. Those inspected include vaccine and drug manufacturers, blood banks, food processing facilities, dairy farms, animal feed processors & compounding pharmacies. US FDA inspections started in India in 2005 and conducted many inspections. The presentation data was up to till 2012. Inspections have been conducted for different therapeutic areas in different parts of India. All such audits in India were verification of study data only.

1. FDA Investigator Inspection:
Global Vs. India
ASIJIT SEN
EMAIL: ASI.JIT.SEN@GMAIL.COM
IN.LINKEDIN.COM/IN/ASIJITSEN
SOURCES: WWW.FDA.GOV

2. FDA Inspection
 FDA inspects manufacturers or processors of FDA-regulated products to verify that
they comply with relevant regulations. Those inspected include
 Vaccine and drug manufacturers
 Blood banks
 Food processing facilities
 Dairy farms
 Animal feed processors
 Compounding pharmacies
2

3. FDA Inspection CONT…
 FDA also inspects
 Facilities that conduct studies in people (clinical trials)
 Laboratories that conduct studies in animals or microorganisms when these studies are
used to apply for FDA approval of a medical product
 Foreign manufacturing and processing sites for FDA-regulated products that are sold in
the United States
 Imported products at the border
 FDA conducts several types of inspections to help protect consumers from unsafe
products
 Pre-approval inspection after a company submits an application to FDA to market a new
product
 Routine inspection of a regulated facility
 “For-cause” inspection to investigate a specific problem that has come to FDA‟s attention
3

4. FDA Inspection: India (2005 – 2012)
 US FDA inspections started in India in 2005
 A total of 40 site inspections conducted between 2005 – 2012
 Inspections have been conducted for 11 therapeutic areas
 Maximum inspection in the field of Psychiatry 30%
 Maximum inspection in the city of Bangalore 23%
 All 40 inspections have been DA i.e. Data Audit. The focus in such audits is
„verification of study data‟
 Deficiency %
 NAI (No Action Initiated) - 65%
 VAI (Voluntary Action Initiated) - 35%
 OAI (Official Action Initiated) – 00%
4

5. Global Clinical Inspections by FDA:
Year-wise & Action Taken
108
172 145 126
161 140 116 101
155 176 189 201 184 162 138 154
25
41
56
44
41 59
25 42
52
70
104 64
50
31
13 00
492
436
360
347
379 416
449
410
328
313 215
350
337
271
161 173
1995 1996 1997 1998 1999 2000 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
#ofClinicalInspectionbyFDA
Year of inspection
No Action Indicated Official Action Indicated Voluntary Action Indicated
5

6. Indian Clinical Inspections by FDA:
Year-wise & Action Taken
6
0 0
4
1
5
3
4
6
2
1
1
1
5
3
2
2
2005 2006 2007 2008 2009 2010 2011 2012
#ofClinicalInspectionbyFDA
Year of inspection
No Action Indicated Voluntary Action Indicated Official Action Initiated

7. 7
No. Name Therapeutic Area Location City Inspection Date Classification
1 Dr. M K Ramesh Surgery Victoria Hospital Bangalore 05-Sep-2005 VAI2
2 Dr. Sachidanand A Sarvajna Murthy Dermatology Victoria Hospital Bangalore 05-Sep-2005 VAI
3 Dr. Anil Abraham Dermatology St John‟s Medical College Bangalore 19-Jun-2006 VAI
4 Dr. Sathianathan Ramanathan Psychiatry Madras Medical College Chennai 16-Apr-2007 NAI
5 Dr. Nadukuru N Raju Psychiatry Government Hospital Mental Care Hyderabad 30-Apr-2007 NAI
6 Dr. Prasad Rao Gundugurti Psychiatry Asha Hospital Hyderabad 05-Jul-2007 NAI
7 Dr. Kenneth Tharayil Dermatology M S Ramaiah Medical College & Hospital Bangalore 01-Aug-2007 NAI
8 Dr. Jitendra K Trivedi Psychiatry Chhatrapati Shahuji Maharaj Medical University Lucknow 04-Sep-2007 VAI
9 Dr. Sathianathan Ramanathan Psychiatry Madras Medical College Chennai 18-Feb-2008 VAI
10 Dr. Sathianathan Ramanathan Psychiatry Madras Medical College Chennai 29-Sep-2008 NAI
11 Dr. Ranjiv K Mahajan Psychiatry Dayanand Medical College & Hospital Ludhiana 09-Jan-2009 VAI
12 Dr. Chandrasekhar K Psychiatry Asha Hospital Hyderabad 19-Jan-2009 NAI
13 Dr. Rupam Borgohain Neurology Nizam's Institute Medical Sciences Hyderabad 09-Jul-2009 VAI
14 Dr. Mariappa Srinivasa Psychiatry Spandana Nursing Home Bangalore 09-Jul-2009 VAI
15 Dr. Raghunadharao Digumarti Oncology Nizam's Institute Medical Sciences Hyderabad 12-Aug-2009 NAI
16 Dr. Shamsher Dwivedee Psychiatry VIMHANS New Delhi 31-Aug-2009 VAI
17 Dr. Yasmin R Bhagat Ophthalmology St George Hospital Mumbai 11-Sep-2009 VAI
18 Dr. Sripada Prasad V Psychiatry Apollo Hospital Hyderabad 12-Oct-2009 NAI
19 Dr. Nita Shanbhag Ophthalmology Omkar Eye Care Centre Mumbai 16-Nov-2009 NAI
20 Dr. Narayanan Pravda Ophthalmology Regional Institute of Ophthalmology Kerala 14-Dec-2009 NAI
21 Dr. Bipin Kumar Sethi Endocrinology Care Hospital Hyderabad 08-Feb-2010 VAI
22 Dr. Anthony Mesquita TB & Chest TB & Chest Disease Hospital Goa 04-May-2010 NAI
23 Dr. K. T. Shenoy Gastroenterology Sree Gokulam Medical College Trivandrum 12-Jun-2010 NAI
24 Dr. Matthew Thomas Dermatology Kerala Institute of Medical Sciences Kerala 12-Jun-2010 VAI
25 Dr. Sat Pal Garg Ophthalmology R P Centre, AIIMS New Delhi 18-Oct-2010 VAI
26 Dr. Sanjay Reddy Endocrinology Bangalore Diabetes Hospital Bangalore 29-Nov-2010 NAI
27 Dr. Anaita Udwadia Hegde Neurology Jaslok Hospital & Research Centre Mumbai 30-May-2011 VAI
28 Dr. Venu Gopal Jhanwar Psychiatry Deva Mental Health Care Varanasi 02-Jul-2011 NAI
29 Dr. Srikanta Sathyanarayana Endocrinology Jnana Sanjeevini Medical Centre Bangalore 26-Aug-2011 VAI
30 Dr. Pradeep Sambarey Obs & Gyn B. J. Medical College & Sassoon General Hospital Pune 29-Aug-2011 NAI
31 Dr. Vyankatesh Shivane Krishnacharya Diabetology Research Health Institute Mumbai 08-Sep-2011 NAI
32 Dr. Shalini Fusey Obs & Gyn Government Medical College & Hospital Nagpur 09-Sep-2011 NAI
33 Dr. Sreenivasa Murthy Dermatology Life Care Clinic & Research Centre Bangalore 04-Feb-2012 NAI
34 Dr. K Subramanian Krishna Kumar Oncology Meenakshi Mission Hospital and Research Centre Madurai 04-Feb-2012 NAI
35 Dr. Bipin K Sethi Endocrinology Care Hospital Hyderabad 26-Mar-2012 NAI
36 Dr. Gulla Surya Prakash Obs & Gyn Care Hospital Secundrabad 21-May-2012 NAI
37 Dr. Bandgar Tushar Ramkrishna Diabetology Research Health Institute in Diabetes Mumbai 16-Jul-2012 NAI
38 Dr. Sandeep K Gupta Diabetology M. V. Hospital & Research Centre Lucknow 01-Sep-2012 VAI
39 Dr. Anita Ramesh Oncology Sri Ramachandra University Chennai 04-Sep-2012 NAI
40 Dr. Umesh Jalihal Gastroenterology M. S. Ramaiah Memorial Hospital Bangalore 09-Oct-2012 VAI
List of FDA Inspected Sites

8. FDA Inspection in India:
Year - Wise
8
2
1 1
2
10
6 6
8
2005 2006 2007 2008 2009 2010 2011 2012

9. FDA Inspection in India:
Therapeutic - Wise
9
1
1
2
2
3
3
3
4
4
5
12
TB & Chest
Surgery
Neurology
Gastroenterology
Oncology
Obs & Gyn
Diabetology
Ophthalmology
Endocrinology
Dermatology
Psychiatry

10. FDA Inspection in India: Deficiency
& Classification Codes - Wise
10
23
2 5
11 10
1 1
Code 00Code 02Code 04Code 05Code 06Code 15Code 18
 Clinical Investigator Inspection List (CIIL) Codes
 Classification Codes:
 NAI - No Action Indicated.
 VAI - Voluntary Action Indicated.
 VAI2 - No response requested.
 OAI - Official Action Indicated.
Code Deficiency CFR Reference
00 No deficiencies noted n/a
02 Failure to obtain and/or document subject consent 21 CFR 312.60, 50.20, 50.27
04 Inadequate drug accountability 21 CFR 312.60, 312.62
05 Failure to follow investigational plan 21 CFR 312.60
06 Inadequate and inaccurate records 21 CFR 312.62
15 Failure to notify IRB of changes, failure to submit progress reports 21 CFR 312.66
18 Other n/a
26
13
1 0
NAI VAI VAI2 OAI

11. FDA Inspections in India:
City - wise
11
1
1
1
1
1
1
1
1
2
2
2
4
5
8
9
Trivnadrum
Varanasi
Goa
Nagupur
Ludhiana
Secundrabad
Pune
Madurai
Kerela
New Delhi
Lucknow
Chennai
Mumbai
Hyderabad
Bangalore