Mylan Nashik and Viatris India: FDA inspection history, 483s and warning letters

The Mylan Nashik FDA inspection history is the public record of nine FDA inspections at Mylan's Sinnar, Nashik facility, seven ending with a Form 483. Searches for a 2026 USFDA audit at Nashik are rising, but the most recent inspection in public FDA records ran from May 13 to 24, 2024, and ended with a Form 483 carrying seven observations.

Those figures come from the Atlas facility records (release of August 15, 2026, checked October 2026), which hold nine Mylan Laboratories Limited sites in India. Mylan has been part of Viatris since November 2020, so FDA letters now go to Viatris while the facilities keep the Mylan name. Below is each facility's record, what FDA cited, and the four warning letters FDA has sent to Mylan's Indian operations.

Key facts:

• FDA has inspected nine Mylan Laboratories Limited facility records in India 57 times, and 35 of those inspections ended with a Form 483 (Atlas, release of August 15, 2026).
• The latest Nashik inspection, May 13 to 24, 2024, ended with a Form 483 citing 21 CFR 211.192, 211.22(d), 211.67(a), 211.58, 211.167(c) and 211.180(c).
• FDA's April 3, 2017 warning letter to Nashik (320-17-32) found that the facility invalidated 101 of 139 initial out-of-specification assay results; FDA closed it out on July 18, 2018.
• FDA issued a warning letter to the Indore facility at Pithampur on December 19, 2024 and placed its products on Import Alert 66-40 the same day.
• 21 CFR 211.192, on investigations of discrepancies and failures, appears on 13 of the 22 Mylan India Form 483s that Atlas holds with observation detail.

Has FDA inspected Mylan Nashik in 2026?

FDA has no 2026 inspection of Mylan Nashik on public record. The Atlas record for Mylan Laboratories Limited, Nasik, Nashik (FEI 3005587313) ends with the May 13 to 24, 2024 inspection, which closed with a Form 483. We also found no 2026 warning letter, FDA posting or trade press report of a new Nashik inspection.

That does not rule out an inspection FDA has not yet published. Form 483s and inspection classifications reach FDA's public data with a lag of months, so a recent visit can sit outside every public dataset. What the record does show is FDA's cadence at Nashik: nine inspections between 2009 and 2024, at intervals of one to four years.

The facility sits at F-4 and F-12, MIDC Malegaon, Sinnar, Nashik, the address on FDA's 2017 warning letter. It has not had a clean FDA inspection since 2012.

What did FDA cite at Mylan Nashik?

FDA's May 2024 Form 483 at Mylan Nashik cited seven observations under six regulations, issued by investigators Wayne D Mcgrath (199 inspections on record) and Arsen Karapetyan (214). The May 24, 2024 Form 483 lists:

1. 21 CFR 211.192, cited twice: discrepancy and failure investigations, and an incomplete written record of an investigation.
2. 21 CFR 211.22(d): quality unit procedures not written or not followed.
3. 21 CFR 211.67(a): equipment cleaning and maintenance.
4. 21 CFR 211.58: buildings not kept in a good state of repair.
5. 21 CFR 211.167(c): test methods for controlled-release products not written or followed.
6. 21 CFR 211.180(c): records not made readily available to FDA.

The last item is worth a second look. 211.180(c) requires records to be available for authorized inspection at the facility. Combined with two 211.192 observations, it points to the same theme FDA raised in 2017: whether the facility's quality data and investigations hold up when an investigator asks for them.

Across the six Nashik Form 483s with observation detail (2011 to 2024), 211.192 appears on five. 211.22(d) and training under 211.25(a) appear on three each. The 2019 and 2020 forms, both written by Kellia N Hicks, cited training and laboratory sample records, then investigations and quality unit procedures. Our analysis of data integrity citations on FDA 483s shows how often these sections travel together.

The 2017 Nashik warning letter and its closeout

FDA inspected Nashik from September 5 to 14, 2016 and issued Warning Letter 320-17-32 on April 3, 2017. It cited two violations:

1. 21 CFR 211.192: from January to June 2016, the facility invalidated 101 of 139 initial out-of-specification assay results, about 72%, without adequate root cause investigation, and left them out of OOS trending.
2. 21 CFR 211.22(a): the quality unit did not investigate audit trail and error messages on HPLC and GC systems that signaled lost or deleted analytical data, including a "deleted result set" entry.

FDA asked for a full data integrity investigation, a risk assessment and a global corrective action plan, and warned it could withhold approvals and refuse admission of products from the facility. On July 18, 2018 FDA issued a closeout letter stating that Mylan appeared to have addressed the violations.

The Atlas record after the closeout is telling. Each of the next three inspections, in 2019, 2020 and 2024, ended with a Form 483, and 211.192 and 211.22(d) returned in 2020 and 2024. The pattern matches what we found at Hetero's Unit V in our Hetero FDA inspection history: a closeout does not mean the next inspection is clean.

Mylan and Viatris facilities in India in FDA's records

FDA records each facility under an FEI number, not under Viatris's internal unit names. These are the nine Mylan Laboratories Limited records Atlas holds for India, all of them in our FDA-inspected sites directory.

Three records carry most of the 483s. Bangalore (8 of 9 inspections), Nashik (7 of 9) and Hosur and Anekal Taluk (6 each) account for 27 of the 35. The largest Hyderabad record is the opposite case: 11 inspections and a single 483, in 2011.

Hosur's five Form 483s with detail all cite 21 CFR 211.42(c)(10), the aseptic processing area controls, and four cite 211.113(b) on sterile contamination. The latest, in May 2024, carried five observations; FDA returned in October 2024 and the inspection was clean. Bangalore and Anekal Taluk both show a Form 483 for January 9 to 16, 2023; neither form has public observation detail.

Since January 2023, FDA has inspected these nine records eight times, and five of those inspections ended with a Form 483 or worse. Atlas has no Mylan India inspection dated 2025 or 2026 in this release.

Which regulations does FDA cite most at Mylan's Indian facilities?

21 CFR 211.192 is the regulation FDA cites most often at Mylan's Indian facilities. Atlas holds 22 Mylan India Form 483s with observation detail, issued from 2011 to 2024 and carrying 159 observations. Counting each section once per form:

211.192 appears at all six facilities with detailed forms: Nashik, Hosur, Bangalore, Anekal Taluk, Aurangabad and Pithampur. The largest single forms were 22 observations at Nashik in March 2015 and 18 at Hosur in May 2017.

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Which Viatris India facilities have FDA warning letters?

Four FDA warning letters have gone to Mylan's Indian operations since 2015, and three of them have been closed out. The open one covers the Indore facility at Pithampur.

Two of those FEIs appear under other names in FDA's data. The Unit 8 API facility (FEI 3002785310) is recorded in Atlas as Matrix Pharmacorp Private Limited, Vizianagaram, a legacy name. The third 2015 FEI is now recorded as OneSource Specialty Pharma Limited, Bengaluru. Our guide to the Form 483 versus the warning letter explains how an inspection moves from one to the other.

What does the import alert on Indore cover?

The import alert on Viatris's Indore facility is Import Alert 66-40, which lets FDA detain drugs from the facility at the US border without physical examination. FDA placed the facility's products on it on December 19, 2024, the date of its warning letter to Viatris. Viatris said in a December 23, 2024 statement that the alert covers 11 actively distributed products, with conditional exceptions for four because of shortage concerns.

FDA records the Indore facility as Mylan Laboratories Limited at Plot Nos. 11, 12 and 13, Indore SEZ Pharma Zone, Pithampur, District Dhar, FEI 3010453141. That is why searches for "Mylan Indore" and "Mylan Pithampur 483" lead to the same record. FDA inspected it from June 14 to 26, 2024. The June 26 Form 483 carried six observations from Pratik S Upadhyay and Steven A Brettler, citing 21 CFR 211.103, 211.160(b), 211.192, 211.22(d), 211.67(a) and 211.68(b).

The warning letter cited two violations:

1. 21 CFR 211.22(d): four worksheets reported passing identification tests, but biometric access records showed the analysts were not at the facility when the tests were documented. Viatris removed five senior staff, including the site head of quality.
2. 21 CFR 211.192: an analyst aborted an HPLC dissolution sequence after out-of-specification and out-of-trend results, and the facility invalidated anomalous assay and content uniformity results without evidence for its root cause.

FDA also asked Viatris to review five years of quality audits across all its facilities. WHO Prequalification ran a for-cause inspection at Pithampur from March 3 to 7, 2025; its March 31, 2025 information note kept the facility's prequalified products current under enhanced checks. We found no FDA closeout letter for Pithampur as of October 2026.

Separately, WHO inspected Mylan's Waluj facility at Chhatrapati Sambhajinagar (formerly Aurangabad) from April 28 to May 2, 2025 and found it compliant with WHO GMP. That report lists a USFDA inspection of February 20 to 28, 2020, the same dates as the clean inspection on the Aurangabad record in Atlas.

What Viatris India's record means for a supplier file

Nashik has not had a clean FDA inspection since 2012, and its 2024 form cites 211.192 and the quality unit section 211.22 again, the two regulations behind its 2017 warning letter. If you source from Nashik, the 2024 Form 483 and Mylan's response are the documents to request.

Pithampur's status is set by the open warning letter. Until FDA closes it, applications naming the facility can be held and its listed products stay on Import Alert 66-40.

Hosur and Bangalore both followed a 483 with a clean inspection, Hosur in October 2024 and Bangalore in February 2023. The FEI matters more than the Viatris brand: these records lead to very different risk ratings. For wider context on how FDA schedules Indian facilities, see our piece on FDA foreign inspections.

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