Biocon Biologics Limited
Form 483 issued August 26, 2022 · Bengaluru, India
- Inspection
- Aug 11 – Aug 26, 2022
- Investigators
- Arsen Karapetyan· Michael R. Shanks· Ralph M. Bernstein
- Observations
- 11
- Pages
- 18
- FEI number
- 3003981475
In short: On August 26, 2022, FDA issued a Form 483 with 11 observations to Biocon Biologics Limited in Bengaluru, Karnataka (FEI 3003981475) after an inspection that ran Aug 11 – Aug 26, 2022. The investigators were Arsen Karapetyan, Michael R. Shanks, Ralph M. Bernstein and Zhong Li. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Facilities & equipment and quality system account for 7 of 11 observations.
Most cited: 21 CFR 211.22 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Your firm's facilities are not adequate to ensure the prevention of contamination of equipment or product…
- 03
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 04
Deviations from written test procedures and laboratory mechanisms are…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmBiocon Biologics Limited history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biocon Biologics Limited?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Biocon Biologics Limited?
Arsen Karapetyan, Michael R. Shanks, Ralph M. Bernstein and Zhong Li are named on this Form 483, for the inspection of Aug 11 – Aug 26, 2022. Each investigator has a profile showing what they cite most.
When was Biocon Biologics Limited inspected by FDA?
The inspection ran Aug 11 – Aug 26, 2022, and the Form 483 is dated August 26, 2022.
How do I get the full Form 483 for Biocon Biologics Limited?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.