Biocon Biologics Limited
Form 483 issued June 3, 2017 · Bangalore, India
- Inspection
- May 25 – Jun 3, 2017
- Investigators
- Eileen A. Liu· Sandra A. Hughes
- Observations
- 2
- Pages
- 8
- FEI number
- 3003981475
In short: On June 3, 2017, FDA issued a Form 483 with 2 observations to Biocon Biologics Limited in Bangalore, India (FEI 3003981475) after an inspection that ran May 25 – Jun 3, 2017. The investigators were Eileen A. Liu and Sandra A. Hughes. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biocon Biologics Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Biocon Biologics Limited?
Eileen A. Liu and Sandra A. Hughes are named on this Form 483, for the inspection of May 25 – Jun 3, 2017. Each investigator has a profile showing what they cite most.
When was Biocon Biologics Limited inspected by FDA?
The inspection ran May 25 – Jun 3, 2017, and the Form 483 is dated June 3, 2017.
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.