Zydus Group
FDA inspection history in Ahmedabad, India, 2012 to 2023
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2012: one close-out letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One close-out letter, at Ahmedabad, India.
- 2023One Form 483, at Ahmedabad, India.
Cited most
Across all Zydus Group observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
The complete Zydus Group 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
Ahmedabad, India
One Form 483 and one close-out letter · 2012 to 2023
Latest: Form 483, Dec 22, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-22 | 483 Form 483 | Ahmedabad, India | — | $99 |
| 2012-07-11 | Close-out Close-out letter | Ahmedabad, India | — | $99 |
FEI number 3006595385 · most recent document Dec 22, 2023
About Zydus Group
How many FDA Form 483s has Zydus Group received?
FDA Intel has 1 Form 483 on file for Zydus Group; the most recent is dated Dec 22, 2023.
When was Zydus Group last inspected by FDA?
The most recent FDA inspection document on file for Zydus Group is a Form 483 dated Dec 22, 2023, for the site in Ahmedabad, India.
What did FDA cite at Zydus Group?
The regulations cited most in the observations on file for Zydus Group 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 211.188 (Batch production and control records), 1 time.