Biocon Biologics Limited
FDA inspection history across 2 sites, 2022 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Bengaluru, India.
- 2022The longest 483 on file: 7 observations over 10 pages at Bengaluru, India.
- 2025One Form 483, at Electronics City Bengaluru, India.
Cited most
Across all Biocon Biologics Limited observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Biocon Biologics 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
Electronics City Bengaluru, India
One Form 483 · 2025 · 5 observations
Latest: Form 483, Sep 3, 2025 →Bengaluru, India
One Form 483 · 2022 · 7 observations
Latest: Form 483, Aug 26, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-03 | 483 Form 483 | Electronics City Bengaluru, India | 5 | $99 |
| 2022-08-26 | 483 Form 483 | Bengaluru, India | 7 | $99 |
Investigators on these documents
Arsen Karapetyan (1)Guerlain Ulysse (1)Ralph M. Bernstein (1)Zhong Li (1)
FEI number 3015283245 · most recent document Sep 3, 2025
About Biocon Biologics Limited
How many FDA Form 483s has Biocon Biologics Limited received?
FDA Intel has 2 Form 483s on file for Biocon Biologics Limited; the most recent is dated Sep 3, 2025.
When was Biocon Biologics Limited last inspected by FDA?
The most recent FDA inspection document on file for Biocon Biologics Limited is a Form 483 dated Sep 3, 2025, for the site in Electronics City Bengaluru, India.
What did FDA cite at Biocon Biologics Limited?
The regulations cited most in the observations on file for Biocon Biologics Limited are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.