Zydus Lifesciences Limited
FDA inspection history in Thane, India, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Thane, India.
Cited most
Across all Zydus Lifesciences Limited observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.80General requirements1
The complete Zydus Lifesciences Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Thane, India
One Form 483 · 2018 · 4 observations
Latest: Form 483, Aug 10, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-10 | 483 Form 483 | Thane, India | 4 | $99 |
Investigators on these documents
FEI number 3006809732 · most recent document Aug 10, 2018
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 Aug 10, 2018.
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 10, 2018, for the site in Thane, 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 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.166 (Stability testing), 1 time.