Biocon Limited
FDA inspection history across 2 sites, 2020 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Bommasandra Post, India.
- 2020The longest 483 on file: 5 observations over 4 pages at Bommasandra Post, India.
- 2024One Form 483, at Bengaluru, India.
Cited most
Across all Biocon Limited observations on file
- 21 CFR 211.186Master production and control records2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
The complete Biocon Limited file.
All 2 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
Bengaluru, India
One Form 483 · 2024 · 4 observations
Latest: Form 483, Sep 27, 2024 →Bommasandra Post, India
One Form 483 · 2020 · 5 observations
Latest: Form 483, Jan 24, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-27 | 483 Form 483 | Bengaluru, India | 4 | $99 |
| 2020-01-24 | 483 Form 483 | Bommasandra Post, India | 5 | $99 |
Investigators on these documents
FEI number 3010164491 · most recent document Sep 27, 2024
About Biocon Limited
How many FDA Form 483s has Biocon Limited received?
FDA Intel has 2 Form 483s on file for Biocon Limited; the most recent is dated Sep 27, 2024.
When was Biocon Limited last inspected by FDA?
The most recent FDA inspection document on file for Biocon Limited is a Form 483 dated Sep 27, 2024, 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 211.186 (Master production and control records), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.