Zydus Lifesciences Limited
FDA inspection history in Ahmedabad, India, 2011 to 2022
- 2
- Form 483s
- 2
- Warning letters
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
- Warning letter
2011: one warning letter; 2015: one warning letter; 2019: one close-out letter and one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at Ahmedabad, India.
- 2015One warning letter, at Ahmedabad, India.
- 2019One close-out letter and one Form 483, at Ahmedabad, India.
- 2019The longest 483 on file: 14 observations over 23 pages at Ahmedabad, India.
- 2022One Form 483, at Ahmedabad, India.
Cited most
Across all Zydus Lifesciences Limited observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features3
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.192Production record review2
- 21 CFR 211.110(b)Sampling and testing of in-process materials and drug products1
The complete Zydus Lifesciences Limited file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Ahmedabad, India
Two Form 483s, two warning letters and one close-out letter · 2011 to 2022 · 18 observations
Latest: Form 483, Aug 5, 2022 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-08-05 | 483 Form 483 | Ahmedabad, India | 4 | $99 |
| 2019-10-29 | Close-out Close-out letter | Ahmedabad, India | — | $99 |
| 2019-05-03 | 483 Form 483 | Ahmedabad, India | 14 | $99 |
| 2015-12-23 | Warning letter Warning letter | Ahmedabad, India | — | $99 |
| 2011-06-21 | Warning letter Warning letter | Ahmedabad, India | — | $99 |
Investigators on these documents
FEI number 3002984011 · most recent document Aug 5, 2022
About Zydus Lifesciences Limited
How many FDA Form 483s has Zydus Lifesciences Limited received?
FDA Intel has 2 Form 483s on file for Zydus Lifesciences Limited; the most recent is dated Aug 5, 2022.
When was Zydus Lifesciences Limited last inspected by FDA?
The most recent FDA inspection document on file for Zydus Lifesciences Limited is a Form 483 dated Aug 5, 2022, for the site in Ahmedabad, India.
What did FDA cite at Zydus Lifesciences Limited?
The regulations cited most in the observations on file for Zydus Lifesciences Limited are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 3 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times.
Has Zydus Lifesciences Limited received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Zydus Lifesciences Limited; the most recent is dated Dec 23, 2015.