Biocon Biologics Limited
FDA inspection history across 3 sites, 2017 to 2024
- 8
- Form 483s
Every document, by year
- Form 483
2017: two Form 483s; 2018: one Form 483; 2019: two Form 483s; 2022: two Form 483s; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Five Form 483s, at Bangalore, India and Bengaluru, India.
- 2022–24Three Form 483s, at Bengaluru, India and Bengalurn, India.
- 2022The longest 483 on file: 11 observations over 18 pages at Bengaluru, India.
Cited most
Across all Biocon Biologics Limited observations on file
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.192Production record review5
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements3
- 21 CFR 211.22Responsibilities of quality control unit3
The complete Biocon Biologics Limited file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Bangalore, India
Four Form 483s · 2017 to 2019 · 6 observations
Latest: Form 483, Feb 15, 2019 →Bengaluru, India
Three Form 483s · 2019 to 2022 · 20 observations
Latest: Form 483, Aug 26, 2022 →Bengalurn, India
One Form 483 · 2024 · 10 observations
Latest: Form 483, Jul 26, 2024 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-26 | 483 Form 483 | Bengalurn, India | 10 | $99 |
| 2022-08-26 | 483 Form 483 | Bengaluru, India | 11 | $99 |
| 2022-08-13 | 483 Form 483 | Bengaluru, India | 1 | $99 |
| 2019-09-19 | 483 Form 483 | Bengaluru, India | 8 | $99 |
| 2019-02-15 | 483 Form 483 | Bangalore, India | 1 | $99 |
| 2018-05-01 | 483 Form 483 | Bangalore, India | 2 | $99 |
| 2017-06-03 | 483 Form 483 | Bangalore, India | 2 | $99 |
| 2017-04-07 | 483 Form 483 | Bangalore, India | 1 | $99 |
Investigators on these documents
Michael R. Shanks (4)Arsen Karapetyan (2)Ralph M. Bernstein (2)Richard Ledwidge (2)Zhong Li (2)Kristen Nickens (1)Lakshmi Naresimban (1)Laura Fontan (1)Laurie Nelson (1)Lindsey Brown (1)Maria Teresa Gutierroz-Lugo (1)Merry Christie (1)
FEI number 3003981475 · most recent document Jul 26, 2024
About Biocon Biologics Limited
How many FDA Form 483s has Biocon Biologics Limited received?
FDA Intel has 8 Form 483s on file for Biocon Biologics Limited; the most recent is dated Jul 26, 2024.
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 Jul 26, 2024, for the site in Bengalurn, 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 211.113 (Control of microbiological contamination), 7 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.