Mylan Laboratories Limited
Form 483 issued May 24, 2024 · Nashik, India
- Inspection
- May 13 – May 24, 2024
- Investigators
- Arsen Karapetyan· Wayne D. McGrath
- Observations
- 7
- Pages
- 15
- FEI number
- 3005587313
In short: On May 24, 2024, FDA issued a Form 483 with 7 observations to Mylan Laboratories Limited in Nashik, Maharashtra (FEI 3005587313) after an inspection that ran May 13 – May 24, 2024. The investigators were Arsen Karapetyan and Wayne D. McGrath. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 6 of 7 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Test procedures describing the testing of yyy: dosage form drug product are…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmMylan Laboratories Limited history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mylan Laboratories Limited?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Mylan Laboratories Limited?
Arsen Karapetyan and Wayne D. McGrath are named on this Form 483, for the inspection of May 13 – May 24, 2024. Each investigator has a profile showing what they cite most.
When was Mylan Laboratories Limited inspected by FDA?
The inspection ran May 13 – May 24, 2024, and the Form 483 is dated May 24, 2024.
How do I get the full Form 483 for Mylan Laboratories Limited?
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