Biocon Biologics Limited
Form 483 issued September 3, 2025 · Electronics City Bengaluru, India
- Inspection
- Sep 3, 2025
- Investigator
- Guerlain Ulysse
- Observations
- 5
- Pages
- 9
- FEI number
- 3015283245
In short: On September 3, 2025, FDA issued a Form 483 with 5 observations to Biocon Biologics Limited in Electronics City Bengaluru, Karnataka (FEI 3015283245) after an inspection that ran Sep 3, 2025. The investigator was Guerlain Ulysse. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written sanitation and facility maintenance procedures are…
- 02
Written procedures are not established or followed for the cleaning and maintenance of equipment, including utensils…
- 03
There is a failure to thoroughly review any unexplained discrepancy and make a record…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biocon Biologics Limited?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Biocon Biologics Limited?
Guerlain Ulysse is named on this Form 483, for the inspection of Sep 3, 2025. Each investigator has a profile showing what they cite most.
When was Biocon Biologics Limited inspected by FDA?
The inspection ran Sep 3, 2025, and the Form 483 is dated September 3, 2025.
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.