Biocon Biologics Limited
Form 483 issued July 26, 2024 · Bengalurn, India
- Inspection
- Jul 15 – Jul 26, 2024
- Investigators
- Justin A. Boyd· Richard Ledwidge· Teresa I. Navas
- Observations
- 10
- Pages
- 14
- FEI number
- 3003981475
In short: On July 26, 2024, FDA issued a Form 483 with 10 observations to Biocon Biologics Limited in Bengalurn, Karnataka (FEI 3003981475) after an inspection that ran Jul 15 – Jul 26, 2024. The investigators were Justin A. Boyd, Richard Ledwidge, Teresa I. Navas and Xiaoshi Wang. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 7 of 10 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (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 did not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Laboratory test procedures and controls are…
- 04
Computerized systems lack controls and review of electronic data to…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biocon Biologics Limited?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Biocon Biologics Limited?
Justin A. Boyd, Richard Ledwidge, Teresa I. Navas and Xiaoshi Wang are named on this Form 483, for the inspection of Jul 15 – Jul 26, 2024. Each investigator has a profile showing what they cite most.
When was Biocon Biologics Limited inspected by FDA?
The inspection ran Jul 15 – Jul 26, 2024, and the Form 483 is dated July 26, 2024.
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.