Galentic Pharma (India) Private Limited
FDA inspection history in Gandhidham, India, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Gandhidham, India.
Cited most
Across all Galentic Pharma (India) Private Limited observations on file
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(a)(3)Stability testing1
The complete Galentic Pharma (India) Private Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Gandhidham, India
One Form 483 · 2022 · 10 observations
Latest: Form 483, Dec 8, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-08 | 483 Form 483 | Gandhidham, India | 10 | $99 |
Investigators on these documents
FEI number 3012178852 · most recent document Dec 8, 2022
About Galentic Pharma (India) Private Limited
How many FDA Form 483s has Galentic Pharma (India) Private Limited received?
FDA Intel has 1 Form 483 on file for Galentic Pharma (India) Private Limited; the most recent is dated Dec 8, 2022.
When was Galentic Pharma (India) Private Limited last inspected by FDA?
The most recent FDA inspection document on file for Galentic Pharma (India) Private Limited is a Form 483 dated Dec 8, 2022, for the site in Gandhidham, India.
What did FDA cite at Galentic Pharma (India) Private Limited?
The regulations cited most in the observations on file for Galentic Pharma (India) Private Limited are 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 211.160(b) (General requirements), 1 time.