Apothecon Pharmaceuticals Private Limited
FDA inspection history in Vadodara, India, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Vadodara, India.
Cited most
Across all Apothecon Pharmaceuticals Private Limited observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.204Returned drug products1
The complete Apothecon Pharmaceuticals Private Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Vadodara, India
One Form 483 · 2023 · 6 observations
Latest: Form 483, Jan 27, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-27 | 483 Form 483 | Vadodara, India | 6 | $99 |
Investigators on these documents
FEI number 3008405956 · most recent document Jan 27, 2023
About Apothecon Pharmaceuticals Private Limited
How many FDA Form 483s has Apothecon Pharmaceuticals Private Limited received?
FDA Intel has 1 Form 483 on file for Apothecon Pharmaceuticals Private Limited; the most recent is dated Jan 27, 2023.
When was Apothecon Pharmaceuticals Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Apothecon Pharmaceuticals Private Limited is a Form 483 dated Jan 27, 2023, for the site in Vadodara, India.
What did FDA cite at Apothecon Pharmaceuticals Private Limited?
The regulations cited most in the observations on file for Apothecon Pharmaceuticals Private Limited are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.