Gland Pharma FDA inspection history: the Dundigal 483, every facility and Cenexi

Gland Pharma's FDA inspection history is the public record of 48 FDA inspections at nine Gland Pharma and Cenexi facility records in India, France and Belgium, 30 of which ended with a Form 483. The newest entry is not yet in any FDA dataset: an unannounced inspection of the Dundigal formulation facility in Hyderabad from October 12 to 23, 2026, which closed with a Form 483 carrying four observations.

Gland disclosed that result to the stock exchanges on October 23, 2026. The counts above come from Atlas facility records (release of August 15, 2026, pulled November 2026): six Gland Pharma Limited records in India and three Cenexi records in Europe. This page covers the 2026 inspection, which FDA record Dundigal is, each facility's history, the citation FDA keeps writing at Gland's sterile facilities and the steps that follow a Form 483.

Key facts:

• FDA inspected Gland Pharma and Cenexi facility records 48 times between 2003 and February 2025, and 30 of those inspections ended with a Form 483 (Atlas, release of August 15, 2026).
• The October 12 to 23, 2026 Dundigal inspection ended with a Form 483 listing four observations, which Gland called procedural and said were neither repeat observations nor related to data integrity.
• Dundigal (FEI 3002647489) holds 11 FDA inspections in Atlas, seven ending with a Form 483 and 32 observations across those seven forms.
• 21 CFR 211.113(b), on procedures to prevent microbial contamination of sterile drug products, appears on 10 of the 22 Gland and Cenexi Form 483s that Atlas holds with observation detail.
• Gland's three Form 483s of 2024 and 2025 were each followed by an Establishment Inspection Report (EIR) that Gland disclosed four to six months after the inspection closed.

What happened at the Gland Pharma Dundigal inspection in October 2026?

The Gland Pharma Dundigal inspection was an unannounced current good manufacturing practice (cGMP) inspection of the company's formulation facility at Dundigal, Hyderabad, from October 12 to 23, 2026. It closed with a Form 483 carrying four observations. Gland received the form on October 23 and disclosed it the same day.

Gland's filing to NSE and BSE and the Indian Pharma Post report of October 24 carry the same four points:

1. The observations are procedural in nature.
2. They are neither repeat observations nor related to data integrity.
3. Gland will send FDA its corrective and preventive actions within the stipulated period.
4. The filing lists the financial and operational impact as "Not Applicable".

All four points are Gland's own characterization. FDA has not published the form and Atlas does not hold it yet, because the current Atlas release covers inspections through mid-2026. Until a later release adds it, nobody outside Gland and FDA can say which 21 CFR sections the form cites or which investigators signed it. 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.

Gland has used the same wording before. Its disclosures for Dundigal in July 2024, Pashamylaram in August 2024 and the JNPC facility at Visakhapatnam in February 2025 also called the observations procedural, not repeated and not related to data integrity.

Did Gland Pharma shares fall after the Dundigal observations?

We found no press report tying a Gland Pharma share move to the October 2026 Dundigal disclosure as of November 6, 2026. The last FDA-linked move we found in the press came in August 2024. On August 5, 2024, after the three-observation Form 483 at Pashamylaram, Gland shares fell as much as 6% intraday to ₹2,000.05, Business Standard reported, while the BSE Sensex traded 2.6% lower that morning. These are reported price moves; Atlas does not give investment advice.

Which FDA record is the Dundigal facility?

The Dundigal facility is the Atlas record Gland Pharma Limited, Hyderabad, FEI 3002647489. FDA files the facility under the city name Hyderabad, not Dundigal, so we matched on dates. Gland's disclosures place Dundigal inspections on July 3 to 14, 2023 and July 22 to 25, 2024, and the Atlas record holds inspections with exactly those dates, ending with one and two observations as Gland reported.

Atlas holds 11 FDA inspections for the record. The table adds the October 2026 inspection from Gland's disclosure:

Jeffrey P Raimondi and Roger F Zabinski wrote the July 25, 2024 Dundigal Form 483, citing record retention (211.180(b)) and quality unit procedures (211.22(d)). Atlas puts Raimondi at 111 inspections and Zabinski at 133. Alan P Kurtzberg and Youkeun Kim wrote the 2023 form. Atlas ties 13 investigators to the Dundigal record in all.

The forms have shrunk. Dundigal averaged 7 observations a form from 2012 to 2019 and has averaged 1.3 since 2022, and 21 CFR 211.192, on investigations of discrepancies, appears on the 2012, 2015 and 2019 forms but on none since.

Gland Pharma facilities in FDA's records

FDA files each facility under an FEI number and the city on the registration, not under Gland's own facility names. Atlas holds six Gland Pharma Limited records and three Cenexi records, all searchable in our FDA-inspected sites directory.

Pashamylaram has the heaviest record after Dundigal: six Form 483s in seven inspections and 23 observations. Its latest form, dated August 2, 2024, cites 211.113(b), 211.22(d) and 211.42(c)(10)(iv), and Gland disclosed an EIR for that inspection on January 18, 2025. The JNPC record matches Gland's disclosure of a sterile API pre-approval inspection from February 19 to 25, 2025, which ended with three observations. Ashar P Parikh, who has 168 inspections on record in Atlas, wrote that form.

Two Visakhapatnam events postdate the Atlas release. Gland disclosed a routine inspection of its VSEZ sterile oncology formulations and API facility from August 24 to September 1, 2026 that ended with zero observations. We have not matched VSEZ to one of the two Visakhapatnam FEIs, so the table leaves both records unlabeled. The 2008 Hyderabad record is also unlabeled, since no document we found ties it to a named Gland facility.

Search results for Gland also return Gland Chemicals Private Limited, with records in Chennai, Malur and Aurangabad. We found nothing tying that company to Gland Pharma and leave it out of every count here.

What has FDA cited most at Gland's sterile facilities?

FDA has cited 21 CFR 211.113(b) more than any other section across the Gland group. 21 CFR 211.113(b) requires written, followed procedures to prevent microbial contamination of sterile drug products, including validation of every aseptic and sterilization process. In Atlas (release of August 15, 2026) it appears on 6 of the 15 Gland Pharma forms with observation detail and on 4 of the 7 Cenexi forms.

The Gland forms citing 211.113(b) span four records: Dundigal in 2012, Pashamylaram in 2015, 2018 and 2024, Visakhapatnam in 2019 and JNPC in 2025.

The same investigators have covered several Gland facilities. Raimondi and Zabinski closed Dundigal on July 25, 2024 and moved to Pashamylaram, where their form followed eight days later. Both forms cite 211.22(d). Michael A Charles, with 243 inspections on record, wrote the May 2019 Dundigal form (seven observations) and the November 2019 Pashamylaram form (four). Jose A Cruz Gonzalez wrote the 11-observation Dundigal form of 2012 and the 9-observation Cenexi Fontenay-sous-Bois form of 2015.

If Gland fills product for you, the investigators in this section are the ones who inspected its Hyderabad facilities most recently, and their past citations show what they check.

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What did FDA find at the Cenexi facilities?

FDA wrote 11 Form 483s across the three Cenexi records in Atlas, with 42 observations on the forms that have detail. Every one of those inspections came before Gland completed its acquisition of the Cenexi group on April 27, 2023, so the record describes the facilities Gland bought, not its own management of them. Cenexi runs four manufacturing sites, three in France and one in Belgium; Atlas holds no FDA record for the fourth.

Fontenay-sous-Bois carries most of the weight: four Form 483s in five inspections and 33 observations. Its December 21, 2018 form, written by Yasamin Ameri, lists eight observations, among them 211.113(b), 211.192 and environmental monitoring under 211.42(c)(10)(iv). Braine-l'Alleud's December 6, 2022 form, written by Nancy M Espinal, has seven observations, including 211.22(a) on quality unit authority and 211.25(c) on staffing levels. Osny's last FDA inspection, in July 2016, was clean.

FDA is not the only regulator at Fontenay. Gland told the exchanges on June 4, 2025 that France's ANSM issued a final report with 11 observations after a GMP inspection there from December 9 to 19, 2024, and that ANSM accepted Cenexi's corrective action plan.

What happens after the October 2026 Form 483 at Dundigal?

After the October 2026 Form 483, Gland sends FDA its corrective and preventive actions. FDA asks for a response within 15 business days if the firm wants it considered before FDA decides on regulatory action. FDA then reviews the inspection report and the response and classifies the inspection as NAI, VAI or OAI.

1. Response. FDA gives weight to a response that answers each of the four observations with root cause, corrective action and evidence.
2. Classification. FDA classifies the inspection after it reviews the record; our explainer on NAI, VAI and OAI covers what each outcome means.
3. EIR. Gland disclosed EIRs for Dundigal on January 16, 2025 and for Pashamylaram on January 18, 2025, about six months after each 2024 inspection closed, and for JNPC on June 24, 2025, four months after its inspection.
4. Data. The form, its CFR sections and its investigators reach a later Atlas release, and we will add them to the Dundigal record then.

The Granules India inspection history and the Mylan Viatris India history show the harder path, where a Form 483 at a Hyderabad or Nashik facility followed a warning letter. Gland's record has no warning letter outcome on any of the nine records in Atlas, and its three most recent disclosed Form 483s ended in EIRs.

What the Gland record means for a supplier file

For a sterile injectable supplier, the classification FDA gives the October 2026 Dundigal inspection sets the facility's status for the next cycle. If you source from Dundigal, ask Gland for the 2026 Form 483, its CAPA response and, once FDA issues one, the EIR.

The rest of the group carries different risk under the same name. Pashamylaram's 2024 form sits on a six-for-seven record of Form 483s. The VSEZ facility reported zero observations in September 2026, and the Cenexi records date from before Gland's ownership. In an audit at any Gland facility, start with sterile process validation (211.113(b)) and investigations (211.192), the two sections FDA has cited most across the group. Our breakdown of FDA investigators in India shows who inspects Indian facilities and what they cite.

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