Centaur Pharmaceuticals Private Ltd.
FDA inspection history across 2 sites, 2022 to 2023
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One Form 483 and one warning letter, at Thane, India and Mumbai, India.
Cited most
Across all Centaur Pharmaceuticals Private observations on file
- 21 CFR 211.194Laboratory records3
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.180General requirements1
The complete Centaur Pharmaceuticals Private file.
All 3 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
Thane, India
One Form 483 and one close-out letter · 2022 · 9 observations
Latest: Form 483, Nov 21, 2022 →Mumbai, India
One warning letter · 2023
Latest: Warning letter, Jun 5, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-05 | Warning letter Warning letter | Mumbai, India | — | $99 |
| 2022-11-21 | 483 Form 483 | Thane, India | 9 | $99 |
| Undated | Close-out Close-out letter | Thane, India | — | $99 |
FEI number 3003973520 · most recent document Jun 5, 2023
About Centaur Pharmaceuticals Private Ltd.
How many FDA Form 483s has Centaur Pharmaceuticals Private Ltd. received?
FDA Intel has 1 Form 483 on file for Centaur Pharmaceuticals Private Ltd.; the most recent is dated Nov 21, 2022.
When was Centaur Pharmaceuticals Private Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Centaur Pharmaceuticals Private Ltd. is a Form 483 dated Nov 21, 2022, for the site in Thane, India.
What did FDA cite at Centaur Pharmaceuticals Private Ltd.?
The regulations cited most in the observations on file for Centaur Pharmaceuticals Private Ltd. are 21 CFR 211.194 (Laboratory records), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.
Has Centaur Pharmaceuticals Private Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Centaur Pharmaceuticals Private Ltd.; the most recent is dated Jun 5, 2023.