Biocon Biologics Limited
Form 483 issued August 26, 2022 · Bengaluru, India
- Inspection
- Aug 23 – Aug 26, 2022
- Investigators
- Arsen Karapetyan· Ralph M. Bernstein· Zhong Li
- Observations
- 7
- Pages
- 10
- FEI number
- 3015283245
In short: On August 26, 2022, FDA issued a Form 483 with 7 observations to Biocon Biologics Limited in Bengaluru, Karnataka (FEI 3015283245) after an inspection that ran Aug 23 – Aug 26, 2022. The investigators were Arsen Karapetyan, Ralph M. Bernstein and Zhong Li. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.68 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
We observed soiled floors. cracked floors wilh peeling paini. dmnagcd 'Wlllls, excessive c-aulking…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Supervisory oversight over the laboratory and manufacturing systems, including the electronic systems…
- 04
Written procedures describing the handling of complaints do not include the provisions for review by the…
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 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biocon Biologics Limited?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Biocon Biologics Limited?
Arsen Karapetyan, Ralph M. Bernstein and Zhong Li are named on this Form 483, for the inspection of Aug 23 – 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 23 – 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.