Torrent Pharmaceuticals FDA inspection history: Indrad, Dahej and every Form 483

Torrent Pharmaceuticals' FDA inspection history is the public record of 40 FDA inspections at eight Torrent facility records in India and the United States, 24 of which ended with a Form 483. The record centers on the Indrad formulation facility in Gujarat, which received FDA warning letter 320-20-03 in October 2019 and a close-out letter for it in September 2024.

The counts come from Atlas facility records (release of August 15, 2026, pulled November 2026) and FDA's inspection classification data through October 2026. This page covers the warning letter, each facility's record, the sections FDA cites most often across Torrent, and where each facility stands as of November 2026.

Key facts:

• FDA inspected eight Torrent facility records 40 times between 2006 and April 2026, and 24 of those inspections ended with a Form 483 (Atlas, release of August 15, 2026).
• Indrad (FEI 3005029956) holds 10 FDA inspections in Atlas, 8 ending with a Form 483 or worse, including the April 2019 inspection that led to warning letter 320-20-03.
• FDA closed warning letter 320-20-03 with a close-out letter dated September 4, 2024, after an Indrad inspection in June 2024 ended in a Form 483 with five observations.
• 21 CFR 211.192, on investigations of discrepancies and failures, appears on 4 of the 9 Torrent Form 483s that Atlas holds with observation detail, and it is the second violation in the 2019 warning letter.
• Three Torrent facilities closed their most recent FDA inspection as No Action Indicated (NAI): Visakhapatnam in August 2025, Dahej in January 2026 and Bileshwarpura in April 2026.

What did the 2019 FDA warning letter to Torrent's Indrad facility cite?

The 2019 FDA warning letter to Torrent, numbered 320-20-03 and dated October 8, 2019, followed an inspection of the Indrad facility from April 8 to 16, 2019. CDER cited two CGMP violations: 21 CFR 211.100(b), for not following an approved process validation protocol, and 21 CFR 211.192, for not thoroughly investigating batch failures and out-of-specification (OOS) results.

The first violation concerned Losartan Potassium Tablets USP, 50 mg and 100 mg. Torrent was qualifying an alternate active pharmaceutical ingredient (API) under a protocol that required three consecutive batches to meet their quality attributes. According to the letter:

1. The first of the three validation batches failed, and a fourth batch was added outside the protocol.
2. The fourth batch failed dissolution, and the quality unit rejected all four.
3. Torrent then used an interim protocol to justify commercial use, and commercial batches reached the US market.
4. Several Losartan batches were later recalled for nitrosamine impurities.

The second violation covered OOS investigations closed without a root cause, with failing initial results invalidated in favor of retests. FDA called it a repeat observation from its April 17 to 28, 2017 inspection of Indrad.

The letter reached beyond Indrad. FDA wrote that it had cited a similar inadequate-investigation observation at the Dahej facility (FEI 3010228235) during a March 11 to 19, 2019 inspection, and that repeated failures at multiple sites showed "executive management oversight and control over the manufacture of drugs is inadequate." It recommended that any consultant Torrent used be qualified as set out in 21 CFR 211.34.

Torrent had disclosed the OAI classification for the April 2019 inspection in August 2019, before the letter arrived. Our explainer on NAI, VAI and OAI covers what each classification means for a facility.

Is the Torrent Indrad warning letter closed?

Yes. FDA issued a close-out letter for warning letter 320-20-03 on September 4, 2024. The close-out says "it appears that you have addressed the violations contained in this Warning Letter," and that future inspections will assess whether the corrections are adequate and sustained.

Indrad did not go straight from the letter to the close-out. FDA inspected the facility again from September 19 to 28, 2022 and issued a Form 483 with three observations, citing 21 CFR 211.192 (investigations), 211.198(b)(2) (complaint records) and 211.67(a) (equipment cleaning and maintenance). Torrent disclosed on January 24, 2023 that FDA had classified that inspection as OAI, as Free Press Journal reported.

The next inspection, a pre-approval and GMP inspection from June 3 to 12, 2024, ended with a Form 483 carrying five observations. Torrent then reported an Establishment Inspection Report (EIR) with a VAI classification for that inspection in August 2024, Pharma Now reported. The close-out letter followed in September.

What did the June 2024 Indrad Form 483 find?

The June 2024 Indrad Form 483 lists five observations, three under finished product and two under API manufacturing. FDA marked two of them as repeat observations from the September 2022 inspection: the investigation of unexplained discrepancies and the cleaning and maintenance of equipment.

Of the 70 OOT batches in observation 1, 34 were OOT for assay and 35 for dissolution. Observation 2 is written in the language of 21 CFR 211.192, the same section as the 2019 letter's second violation, which places it on three consecutive Indrad records: 2019, 2022 and 2024. Our guide to 21 CFR 211.192 explains what a defensible investigation file holds.

Pratik S Upadhyay, with 111 inspections and 353 observations on record in Atlas, signed both the 2022 and the 2024 Indrad forms. He co-signed 2022 with Jose E Melendez, who has 182 inspections on record.

Torrent Pharmaceuticals facilities in FDA's records

FDA files each facility under an FEI number and the city on the registration, not under Torrent's own facility names. Atlas holds six Torrent Pharmaceuticals Limited records in India and two Torrent Pharma Inc. records in the US, all searchable in our FDA-inspected sites directory. The Indrad facility record has its own page; the others are listed under their FDA city.

Dahej, which FDA files under Bharuch, has the second-heaviest manufacturing record. Its June 2017 form lists five observations, among them 211.192, 211.22(d) on quality unit procedures and 211.67 on equipment cleaning. FDA classified the March 2019 inspection OAI, and the 2019 Indrad warning letter cites it. A May 2023 re-inspection ended with two observations, 211.192 and 211.68(b), and Torrent reported in August 2023 that FDA had closed it with an EIR, Business Standard reported. FDA's inspection data classifies Dahej's January 19 to 23, 2026 inspection as NAI.

Pithampur, in Madhya Pradesh, is five for five: every FDA inspection since 2011 ended with a Form 483. The latest, September 16 to 20, 2024, had one observation under 21 CFR 211.84(d)(1), identity testing of each component, written by Karen A Briggs and Lillian S Wu. Torrent disclosed a VAI classification for it in November 2024.

The Gandhinagar record with FEI 3012740315 matches the dates Torrent disclosed for its Bileshwarpura oncology facility: a March 2023 inspection with one observation (211.22(d)), a December 2023 pre-approval inspection with five, and an April 6 to 10, 2026 inspection with none. The other Gandhi Nagar record (FEI 3007078804) is different in kind. Its June 2018 form cites 21 CFR 314.80 three times, on postmarketing adverse drug experience reporting, which makes it a drug safety reporting inspection rather than a manufacturing one.

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What does FDA cite most at Torrent facilities?

FDA cites 21 CFR 211.192 more than any other section across Torrent's records. Section 211.192 requires a thorough investigation of any unexplained discrepancy or batch failure, extended to other batches that may be affected. In Atlas (release of August 15, 2026) it appears on 4 of the 9 Torrent Form 483s with observation detail: Indrad 2022, Dahej 2017 and 2023, and Visakhapatnam 2009.

Those nine forms carry 26 observations between them. Add the 2019 warning letter and the June 2024 Indrad form, whose observations follow the wording of 211.192 and 211.67, and investigations and equipment cleaning account for most of what FDA has written about Torrent in the last decade.

Who inspects Torrent's facilities?

Atlas ties 45 FDA investigators to the six Torrent records in India, and most appear on only one of them. Pratik S Upadhyay is the exception: he signed the March 2023 Bileshwarpura form and both the 2022 and 2024 Indrad forms. Kellia N Hicks, with 185 inspections on record, wrote the May 2023 Dahej form. Cheryl A Clausen wrote the May 2016 Indrad form, which cites 211.22(d) and 211.84(c)(4), container sampling, twice each. Our breakdown of FDA investigators in India shows who else inspects Indian facilities and what they cite.

What the Torrent record means for a supplier file

For a company sourcing from Torrent, the facility matters more than the company name. As of November 2026, Dahej, Visakhapatnam and Bileshwarpura each closed their last FDA inspection as NAI, and Indrad and Pithampur closed theirs as VAI. Indrad's warning letter has a close-out letter, but its last three inspections each carried an investigation observation under 211.192 or its wording.

In an audit at Indrad, ask for the June 2024 Form 483, Torrent's response, the EIR and the OOT investigations behind observation 1. At Dahej, ask how the 211.192 and 211.68(b) observations from May 2023 were closed. At any Torrent facility, start with investigations (211.192) and equipment cleaning (211.67), the two areas FDA has cited most across the group. The Gland Pharma inspection history and the Hetero Labs history follow the same facility-by-facility format for two other Indian manufacturers.

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