Mylan Laboratories Limited
FDA inspection history in Bengaluru, India, 2013 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2013: one warning letter; 2020: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One warning letter, at Bengaluru, India.
- 2020One Form 483, at Bengaluru, India.
- 2020The longest 483 on file: 5 observations over 6 pages at Bengaluru, India.
- 2023One Form 483, at Bengaluru, India.
Cited most
Across all Mylan Laboratories Limited observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Mylan Laboratories Limited file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Bengaluru, India
Two Form 483s and one warning letter · 2013 to 2023 · 7 observations
Latest: Form 483, Jan 16, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-16 | 483 Form 483 | Bengaluru, India | 2 | $99 |
| 2020-02-28 | 483 Form 483 | Bengaluru, India | 5 | $99 |
| 2013-09-09 | Warning letter Warning letter | Bengaluru, India | — | $99 |
Investigators on these documents
FEI number 3007648351 · most recent document Jan 16, 2023
About Mylan Laboratories Limited
How many FDA Form 483s has Mylan Laboratories Limited received?
FDA Intel has 2 Form 483s on file for Mylan Laboratories Limited; the most recent is dated Jan 16, 2023.
When was Mylan Laboratories Limited last inspected by FDA?
The most recent FDA inspection document on file for Mylan Laboratories Limited is a Form 483 dated Jan 16, 2023, for the site in Bengaluru, India.
What did FDA cite at Mylan Laboratories Limited?
The regulations cited most in the observations on file for Mylan Laboratories Limited are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Mylan Laboratories Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Mylan Laboratories Limited; the most recent is dated Sep 9, 2013.