Calyx Chemicals & Pharmaceuticals Limited
FDA inspection history in Boisar, 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 Boisar, India.
Cited most
Across all Calyx Chemicals & Pharmaceuticals Limited observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
The complete Calyx Chemicals & Pharmaceuticals Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Boisar, India
One Form 483 · 2019 · 4 observations
Latest: Form 483, Nov 8, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-11-08 | 483 Form 483 | Boisar, India | 4 | $99 |
Investigators on these documents
FEI number 3003721861 · most recent document Nov 8, 2019
About Calyx Chemicals & Pharmaceuticals Limited
How many FDA Form 483s has Calyx Chemicals & Pharmaceuticals Limited received?
FDA Intel has 1 Form 483 on file for Calyx Chemicals & Pharmaceuticals Limited; the most recent is dated Nov 8, 2019.
When was Calyx Chemicals & Pharmaceuticals Limited last inspected by FDA?
The most recent FDA inspection document on file for Calyx Chemicals & Pharmaceuticals Limited is a Form 483 dated Nov 8, 2019, for the site in Boisar, India.
What did FDA cite at Calyx Chemicals & Pharmaceuticals Limited?
The regulations cited most in the observations on file for Calyx Chemicals & Pharmaceuticals Limited are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.192 (Production record review), 1 time.