Zydus Lifesciences Limited
FDA inspection history across 2 sites, 2022 to 2024
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2022: one close-out letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24One close-out letter and one Form 483, at Ahmedabad, India and Matoda, India.
Cited most
Across all Zydus Lifesciences Limited observations on file
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.42(c)(10)(iv)Design and construction features1
- 21 CFR 211.58Maintenance1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
The complete Zydus Lifesciences Limited file.
All 2 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
Matoda, India
One Form 483 · 2024 · 4 observations
Latest: Form 483, Mar 27, 2024 →Ahmedabad, India
One close-out letter · 2022
Latest: Close-out, Nov 3, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-27 | 483 Form 483 | Matoda, India | 4 | $99 |
| 2022-11-03 | Close-out Close-out letter | Ahmedabad, India | — | $99 |
Investigators on these documents
FEI number 3007621329 · most recent document Mar 27, 2024
About Zydus Lifesciences Limited
How many FDA Form 483s has Zydus Lifesciences Limited received?
FDA Intel has 1 Form 483 on file for Zydus Lifesciences Limited; the most recent is dated Mar 27, 2024.
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 Mar 27, 2024, for the site in Matoda, 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 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.42(c)(10)(iv) (Design and construction features), 1 time; 21 CFR 211.58 (Maintenance), 1 time.