Agon Pharma Private Limited
FDA inspection history in Pune, India, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Pune, India.
Cited most
Across all Agon Pharma Private Limited observations on file
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.105(a)Equipment identification1
- 21 CFR 211.188(b)Batch production and control records1
- 21 CFR 211.80(d)General requirements1
The complete Agon Pharma Private Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Pune, India
One Form 483 · 2019 · 4 observations
Latest: Form 483, Jun 13, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-13 | 483 Form 483 | Pune, India | 4 | $99 |
Investigators on these documents
FEI number 3007481629 · most recent document Jun 13, 2019
About Agon Pharma Private Limited
How many FDA Form 483s has Agon Pharma Private Limited received?
FDA Intel has 1 Form 483 on file for Agon Pharma Private Limited; the most recent is dated Jun 13, 2019.
When was Agon Pharma Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Agon Pharma Private Limited is a Form 483 dated Jun 13, 2019, for the site in Pune, India.
What did FDA cite at Agon Pharma Private Limited?
The regulations cited most in the observations on file for Agon Pharma Private Limited are 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.105(a) (Equipment identification), 1 time; 21 CFR 211.188(b) (Batch production and control records), 1 time.