US FDA auditor list for India: the investigators behind 292 Form 483s, 2024 to 2026

A US FDA auditor list for India is a record of the FDA investigators who inspect Indian facilities, rebuilt from the names they sign on Form 483s. FDA publishes no such list. In Atlas data, Kunapuli T Madhusudhan (56 forms), Osama M Hamoud (31) and Roy C Stephens (31) signed the most Indian 483s since January 2024, all at food facilities; Anastasia M Shields and Saleem A Akhtar lead on drugs with 10 each.

This page lists the 19 investigators named on five or more Indian Form 483s, built from the Atlas Form 483 directory (release of August 15, 2026, forms issued January 2024 to July 3, 2026), with the CFR sections each one cited.

• Atlas holds 292 Form 483s with observation detail at Indian facilities from January 2024 to July 2026: 148 human drugs, 137 foods and cosmetics, 7 devices or animal drugs.
• The 292 forms name 106 different FDA investigators; 19 of them appear on five or more.
• Three food investigators are named on 117 of the 137 Indian food 483s.
• On the 148 human-drug forms, 21 CFR 211.22 (quality control unit) is cited on 63 and 21 CFR 211.192 (investigations) on 57.
• FDA's India office ran 139 inspections in fiscal 2025, 47% of them unannounced, and 76 in fiscal 2026 to date, 87% unannounced, according to an FDA Voices article current as of August 3, 2026.

Which FDA investigators inspect facilities in India?

The FDA investigators named on the most Form 483s at Indian facilities from January 2024 to July 2026 are three food investigators, Kunapuli T Madhusudhan, Osama M Hamoud and Roy C Stephens, followed by sixteen human-drug investigators led by Anastasia M Shields and Saleem A Akhtar. Every name links to the person's Atlas profile.

Method: we pulled every Form 483 in the Atlas Form 483 directory issued in 2024, 2025 and 2026 (11,048 forms) and kept the 292 whose inspected site is in India. Each form is credited to every investigator named on it. Observations are credited to an investigator when the form lists that person as citing them. Sections are counted per observation.

Read the counts as inspections in India that ended with a Form 483, not as all inspections in India. A clean inspection leaves no signed public form, so Atlas cannot tie it to a name. That gap shows up on the profiles. Five of the drug investigators in the table, among them Lisa L Flores (Bangalore), Rafeeq A Habeeb (Bangalore) and Pratik S Upadhyay (Daman), have a May 2026 inspection in India as the latest entry on their profile, later than their latest Indian 483 in this release.

A high count measures workload; observations per form show how much an investigator writes. Kunapuli T Madhusudhan's 56 forms went to 55 different facilities and average 6.4 observations each. Rafeeq A Habeeb's eight average under four. The full FDA investigators directory holds the same record for anyone not in the table.

How does FDA staff inspections in India?

FDA staffs inspections in India from two pools: investigators posted at the FDA India Office in New Delhi, set up in November 2008, and US-based investigators who fly in, including a dedicated foreign drug cadre that specializes in overseas work. The Atlas data show both patterns in the names on Indian 483s.

The posted staff is small. GAO report GAO-25-106775 (November 2024) found that four of the seven India office positions were vacant in June 2024, a 57% vacancy rate. The same report counts the US-based dedicated foreign drug cadre at 18 of 21 positions filled. The rest of the foreign workload falls to general investigators who mostly inspect US facilities and travel for foreign trips, and the GAO report on FDA's inspection workforce notes that a larger share of those trips now go to India and China.

The two programs look different in our data. The three food investigators account for 117 of 137 Indian food 483s, and the latest inspection on each of their Atlas profiles is in India (Kuttapuli, Jodhpur and Haridwar, June or July 2026). Human-drug 483s are spread across 90 names, and 47 of those investigators appear on a single Indian form. Of the 16 drug investigators in the table, seven had their latest recorded inspection outside India: Saleem A Akhtar in Reykjavik, Iceland (May 2026), Wayne D Mcgrath in Osaka, Japan, and Justin A Boyd in Pilar, Argentina, both in June 2026. A 483 does not say whether its signer is posted in New Delhi or travelled from the US, so Atlas does not label anyone that way.

FDA has also stopped warning most Indian facilities ahead of a visit. GAO reports that FDA had started 114 pilot inspections in India by May 2024, 94 of them unannounced, with two investigators on each unannounced visit for safety. FDA announced expanded unannounced foreign inspections in May 2025, and its India office reported 87% of fiscal 2026 inspections as unannounced. Our hub on FDA foreign inspections covers the refusal rule and Import Alert 66-79 that sit behind those visits.

Some investigators work in pairs. On Indian drug 483s, Anastasia M Shields and Justin A Boyd share four forms, Wayne D Mcgrath and Arsen Karapetyan share three, and Pratik S Upadhyay and Timothy H Vo share three.

How do you find out which FDA investigator is coming?

An Indian facility finds out which FDA investigator is coming when the investigator shows credentials and issues a signed Form FDA 482, Notice of Inspection, at the start of the visit. FDA does not publish assignments. For a scheduled foreign inspection, the correspondence that sets the dates can name the team; for an unannounced one, the 482 is the first sight of the name.

The steps follow the sequence in FDA's Investigations Operations Manual, explained in our guide to the FDA Investigations Operations Manual:

1. Before the visit, keep the last two years of Indian 483s for your dosage form on file; with no notice, that file is your preparation.
2. At the gate, record each name and middle initial from the credentials and the 482. Every FDA participant signs the 482, and a late joiner issues a new one.
3. The same day, open each investigator's profile and read their Indian 483s and the sections cited. Check the co-investigators too.
4. At close-out, the Form 483 carries each investigator's name and signature. Your written response has 15 business days to reach FDA before it decides on further action.

The middle initial matters. Our US FDA investigator list explains how to match a name on a 482 to the right profile, and why there are two Lisa Flores profiles.

What do the top FDA investigators cite at Indian facilities?

The top FDA investigators in India cite quality unit procedures (21 CFR 211.22(d)) and investigations (21 CFR 211.192) most often at drug facilities, and sterile process control (211.113(b)) most heavily at sterile sites. Food investigators cite preventive controls under 21 CFR Part 117. Across 148 Indian human-drug 483s in Atlas (release of August 15, 2026), 211.22 appears on 63 and 211.192 on 57.

Anastasia M Shields cited 211.113(b) 14 times across her 10 Indian forms, and Justin A Boyd, her most frequent partner, cited it 10 times on five. Arsen Karapetyan's six forms carry eight 211.192 citations. Pratik S Upadhyay leads on laboratory controls, with six 211.160(b) observations. Guerlain Ulysse cited 211.22(d) six times in 21 observations.

Five forms from the directory, each with its investigators:

• Indoco Remedies, Verna, Goa, July 26, 2024: Wayne D Mcgrath and Saleem A Akhtar, seven observations, two under 211.113(b), plus environmental monitoring, complaint handling and facility repair.
• NATCO Pharma, Rangareddy, June 19, 2025: Wayne D Mcgrath and Arsen Karapetyan, seven observations covering sterile procedures, investigations and cleaning.
• Zydus Lifesciences, Matoda, November 13, 2025: Guerlain Ulysse and Rafeeq A Habeeb, two observations, sterile validation and an incomplete investigation record.
• Eugia Pharma Specialities, Sangareddy, February 6, 2026: Patty P Kaewussdangkul, Lisa L Flores and Unnee Ranjan, 11 observations led by two 211.113(b) citations.
• Cipla, Salcette, Goa, April 17, 2026: Jeffrey P Raimondi, Anastasia M Shields and Karishma G Gopaul, two observations, 211.113(b) and 211.22(d).

On food, the 137 Indian forms carry 570 observations. The most cited are 117.135(a)(1), written process preventive controls (41), 117.35(c), pest control (36), and 117.80(a)(2), quality control operations (31). Kunapuli T Madhusudhan cited 117.80(a)(2) on 31 of his observations.

Company-level histories sit in our posts on Mylan and Viatris in India and Hetero Labs, and our analysis of API manufacturer Form 483s covers drug substance sites.

The 16 drug investigators in the table appear on 82 Indian forms, and 60 of those cite 211.113 or 211.192. Before your opening meeting, you can read the forms the investigator on your 482 signed at facilities like yours.

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How complete is a 483-based list of FDA investigators in India?

A 483-based list of FDA investigators in India covers the inspections that ended with a published Form 483 and misses the clean ones. FDA's inspection classification data, as loaded in Atlas, record 911 inspections of Indian facilities closed from January 2024 to July 2026: 359 NAI, 480 VAI and 72 OAI, with 652 of them drug inspections.

The 292 forms with observation detail cover about half of the 552 VAI and OAI inspections. Some VAI inspections end without a 483, and FDA publishes foreign 483 detail with a lag, so the 2026 count will rise in later releases. FDA's classification data carry no investigator names at all, which is why every investigator list starts from the 483.

Use the table as a starting point, then check the profile of the person named on your 482.

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