Granules India USFDA Gagillapur inspection: 11 observations and the full FDA record

FDA inspected Granules India's finished dosage facility at Gagillapur, Hyderabad from October 19 to 30, 2026 and closed with a Form 483 listing 11 observations. Granules disclosed the result on October 31 and said none of the observations involve data integrity or cross-contamination. Manufacturing and distribution continue, and Granules will answer FDA within 15 business days.

Granules India's FDA inspection history is the record of 41 FDA inspections at ten Granules facility records in India and the US, 23 of which ended with a Form 483. The October inspection is not yet in any FDA dataset. The counts here come from Atlas facility records (release of August 15, 2026, pulled November 2026): six Granules India Limited records, one Granules Life Sciences record in India and three US records. This page covers the 2026 inspection, the 2025 warning letter at Gagillapur, each facility's record and the Form 483s FDA has written at Granules Pharmaceuticals Inc. in Chantilly, Virginia.

Key facts:

• FDA inspected Granules facility records 41 times between 2001 and April 2026, and 23 of those inspections ended with a Form 483 or a warning letter outcome (Atlas, release of August 15, 2026).
• The October 19 to 30, 2026 Gagillapur inspection ended with a Form 483 listing 11 observations, according to Granules' October 31, 2026 disclosure.
• FDA issued warning letter 320-25-48 to the Gagillapur facility (FEI 3004097901) on February 26, 2025, citing 21 CFR 211.67(b), 211.58 and 211.68(a).
• Granules Pharmaceuticals Inc. in Chantilly, Virginia received a Form 483 at 10 of its 11 FDA inspections from 2017 to 2026, with 34 observations on record.
• 21 CFR 211.22(d), on quality unit procedures, appears on four of the nine Chantilly Form 483s that Atlas holds with observation detail.

What happened at the Granules Gagillapur inspection in October 2026?

The Granules Gagillapur inspection ran from October 19 to 30, 2026 and ended with a Form 483 carrying 11 observations. Granules called it a current good manufacturing practice inspection of its finished dosage facility at Gagillapur, Hyderabad. It was FDA's first inspection there since the warning letter of February 26, 2025.

Granules announced the outcome on October 31, 2026, and Indian Pharma Post and Medical Dialogues carried the same details that day. According to Granules:

1. The observations relate to investigations, change control, process and equipment qualification, visual-inspection controls and documentation practices.
2. None of the observations relate to data integrity or cross-contamination.
3. Manufacturing and distribution from the site continue.
4. Granules will send FDA a full response within 15 business days.

On the company's Q2 earnings call (Investing.com transcript, published November 2), the company chairman said Granules believes all 11 observations are addressable. An executive director said the remediation plan was complete except for two CAPAs.

All of that comes from Granules. FDA has not published the form and Atlas does not hold it yet: the current Atlas release covers inspections through mid-2026, so the October inspection will appear in a later release. Until then nobody outside Granules and FDA can say which regulations the form cites or who the investigators were. A Form 483 records an investigator's observations at the close of an inspection, and our guide to what an FDA Form 483 is explains why it is not a final agency finding.

How did Granules India shares react to the Gagillapur observations?

Granules India shares closed 2.38% lower at ₹819.55 on the BSE on November 2, 2026, the first trading day after the disclosure, Whalesbook reported, tying the fall to the inspection. Investing.com put the drop at 2.27% and named margin pressure and freight costs alongside the FDA observations.

Gagillapur news has moved the stock harder before. On December 3, 2024, after Granules said FDA had classified the 2024 inspection Official Action Indicated (OAI), the shares fell as much as 11.09% on the BSE, Business Today reported. On February 28, 2025, after the warning letter, they fell as much as 7.65% on the NSE, according to Upstox. These are reported price moves; Atlas does not give investment advice.

Which FDA record is the Gagillapur facility?

The Gagillapur facility is the Atlas record Granules India Limited, Medchal-Malkhajgiri District, FEI 3004097901. FDA's February 26, 2025 warning letter names that FEI and gives the address as Survey No 160/A, 161/E, 162 and 174/A, Gagillapur Village, Dundigal-Gandimaisamma Mandal, Medchal-Malkhajgiri District, Telangana.

We matched on the FEI in the letter, not the city name. A second record, Granules India Limited in Qutbullapur Mandal, Ranga Reddy District (FEI 3004523487), sits in the area Gagillapur belonged to before Telangana redrew its districts in 2016. That record holds two clean inspections, in 2004 and 2007, and no document we found ties it to Gagillapur, so we leave it unlabeled.

Atlas holds eight FDA inspections for the Gagillapur record. The table adds the October 2026 inspection from Granules' disclosure:

Darren S Brown, who has 118 inspections on record in Atlas, wrote the February 14, 2020 Form 483 with Jose A Lopez Rubet. It cited investigations of discrepancies (211.192) and equipment calibration and checks (211.68(a)). Atlas ties 13 investigators to the Gagillapur record in all, among them Pratik S Upadhyay, Joseph A Piechocki and Jogy George.

What did FDA cite in the 2025 Gagillapur warning letter?

FDA's warning letter 320-25-48, issued by CDER on February 26, 2025, cited three regulations after the August 26 to September 6, 2024 inspection. Indian press reported that the inspection's Form 483 carried six observations.

1. 21 CFR 211.67(b): swabs taken downstream of HEPA filters in air handling unit ducts serving non-dedicated equipment found residues of several previously made drug products and microbial counts FDA called "too numerous to count".
2. 21 CFR 211.58: investigators found bird droppings and feathers in the air handling area, on ducts, a tank and floors near manufacturing equipment. Birds entered through gaps in the exterior walls.
3. 21 CFR 211.68(a): the facility did not inspect and maintain its air handling units well enough to keep filters effective, and the equipment maker confirmed damage to certain filters.

FDA also described torn CGMP records, including balance printouts and test worksheets, in at least 15 waste bags, and asked Granules to assess its data integrity controls. The letter warned that FDA could withhold approval of applications naming the facility and refuse admission of its products.

The 2025 letter turned on cross-contamination and data integrity, and Granules says none of the 2026 observations touch either. The categories it did name (investigations, change control, qualification) are the systems FDA checks when it tests whether corrective actions held.

Granules facilities in FDA's records

FDA files each facility under an FEI number and the city on the registration, not under Granules' own facility names. Atlas holds ten Granules records, all searchable in our FDA-inspected sites directory.

The Indian records fall into two groups. Gagillapur, Secunderabad and Sangareddy carry ten Form 483s between them, while Visakhapatnam and Parawada have four inspections and no 483. Secunderabad had 483s in 2009, 2013, 2015 and 2018, then a clean inspection in June 2023. Sangareddy's latest inspection, June 16 to 20, 2025, ended with a 483 whose observations are not public. Granules Life Sciences received 483s at both of its inspections, in July 2025 and December 2025.

Parsippany is the odd one out. Tonia F Bernard's six observations there in December 2016 cite 21 CFR 314.80 and 314.81, for late or incomplete postmarketing safety reports rather than manufacturing.

What has FDA found at Granules Pharmaceuticals Inc. in Chantilly?

Granules Pharmaceuticals Inc. in Chantilly, Virginia has received a Form 483 at 10 of its 11 FDA inspections since December 2017. Its one clean inspection, July 31 to August 3, 2023, came between two 483s. Atlas holds nine of the ten forms with observation detail, 34 observations in all.

Two sections recur. 21 CFR 211.22(d), quality unit procedures not written or not followed, appears on four forms (2017, 2021, July 2022 and 2023), and 21 CFR 211.63, on equipment design, size and location, appears on four more (2018, 2020, July 2022 and 2023). William J Leonard, who has 78 inspections on record, wrote the largest form, 12 observations in July 2022. David A Oluwo, with 82 inspections on record, led both of the last two Chantilly inspections.

If Chantilly is on your supplier list, read the past citations of the investigators in this table before your next audit there.

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What happens after the October 2026 Form 483 at Gagillapur?

After the October 2026 Form 483, Granules has 15 business days to answer FDA in writing, by its own count. FDA then reviews the inspection and the response and classifies the inspection as NAI, VAI or OAI. That classification decides whether the 2025 warning letter can move toward a closeout.

1. Response. FDA gives weight to a response that answers each of the 11 observations with root cause, corrective action and evidence. Our guide to effective FDA Form 483 response strategies sets out what FDA looks for.
2. Classification. FDA classifies the inspection after it reviews the record, and the classification reaches public FDA data months after the inspection closes.
3. Applications. The 2025 letter said FDA could withhold approval of applications that name Gagillapur until the facility is compliant.
4. Closeout. FDA issues a closeout letter only after it verifies corrections. We found no closeout for warning letter 320-25-48 as of November 6, 2026.

We have seen this sequence before. In the Mylan Viatris India inspection history and the Hetero Labs FDA inspection history, the inspections after a warning letter at Mylan Nashik and Hetero Unit V also ended with Form 483s, and the classification that followed mattered more than the observation count.

What the Granules record means for a supplier file

The open warning letter and the classification FDA gives the October 2026 inspection set Gagillapur's status. If you source finished doses from Gagillapur, ask Granules for the 2026 Form 483, its response and, once FDA issues one, the classification letter.

Chantilly drew a 483 at 10 of 11 visits, but its forms have shrunk since July 2022: five observations in 2023, one in 2025 and four in 2026. In an audit there, check quality unit procedures and equipment design first. Visakhapatnam and Secunderabad (both clean in 2023) and Parawada (clean in 2024) carry a different risk profile from Gagillapur under the same company name. Our breakdown of FDA investigators in India shows who inspects Indian facilities and what they cite.

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