Ajanta Pharma Limited
FDA inspection history in Bharuch, India, 2019 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Bharuch, India.
- 2019The longest 483 on file: 3 observations over 2 pages at Bharuch, India.
- 2022One Form 483, at Bharuch, India.
Cited most
Across all Ajanta Pharma Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 111
- 21 CFR 211.160General requirements1
- 21 CFR 211.198Complaint files1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Ajanta Pharma 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
Bharuch, India
Two Form 483s · 2019 to 2022 · 5 observations
Latest: Form 483, Sep 9, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-09 | 483 Form 483 | Bharuch, India | 2 | $99 |
| 2019-06-22 | 483 Form 483 | Bharuch, India | 3 | $99 |
Investigators on these documents
FEI number 3012664809 · most recent document Sep 9, 2022
About Ajanta Pharma Limited
How many FDA Form 483s has Ajanta Pharma Limited received?
FDA Intel has 2 Form 483s on file for Ajanta Pharma Limited; the most recent is dated Sep 9, 2022.
When was Ajanta Pharma Limited last inspected by FDA?
The most recent FDA inspection document on file for Ajanta Pharma Limited is a Form 483 dated Sep 9, 2022, for the site in Bharuch, India.
What did FDA cite at Ajanta Pharma Limited?
The regulations cited most in the observations on file for Ajanta Pharma Limited are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 11, 1 time; 21 CFR 211.160 (General requirements), 1 time.