Biocon Limited
FDA inspection history in Bengaluru, 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 Bengaluru, India.
Cited most
Across all Biocon Limited observations on file
- 21 CFR 211.160General requirements4
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Biocon Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Bengaluru, India
One Form 483 · 2019 · 6 observations
Latest: Form 483, Mar 5, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-03-05 | 483 Form 483 | Bengaluru, India | 6 | $99 |
FEI number 1000172912 · most recent document Mar 5, 2019
About Biocon Limited
How many FDA Form 483s has Biocon Limited received?
FDA Intel has 1 Form 483 on file for Biocon Limited; the most recent is dated Mar 5, 2019.
When was Biocon Limited last inspected by FDA?
The most recent FDA inspection document on file for Biocon Limited is a Form 483 dated Mar 5, 2019, for the site in Bengaluru, India.
What did FDA cite at Biocon Limited?
The regulations cited most in the observations on file for Biocon Limited are 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.194 (Laboratory records), 1 time.