Biocon Biologics Limited
Form 483 issued May 1, 2018 · Bangalore, India
- Inspection
- Apr 23 – May 1, 2018
- Investigators
- Laura Fontan· Laurie Nelson
- Observations
- 2
- Pages
- 4
- FEI number
- 3003981475
In short: On May 1, 2018, FDA issued a Form 483 with 2 observations to Biocon Biologics Limited in Bangalore, Karnataka (FEI 3003981475) after an inspection that ran Apr 23 – May 1, 2018. The investigators were Laura Fontan and Laurie Nelson. 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 2 of 2 observations.
Most cited: 21 CFR 211.113 (2×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Disinfection efficacy is incomplete…
- 02
Environmental monitoring is…
This inspection in context
Laura Fontan
8 documents · 2017–2022
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
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 2 observations on this Form 483, mostly about facilities & equipment and production. 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?
Laura Fontan and Laurie Nelson are named on this Form 483, for the inspection of Apr 23 – May 1, 2018. Each investigator has a profile showing what they cite most.
When was Biocon Biologics Limited inspected by FDA?
The inspection ran Apr 23 – May 1, 2018, and the Form 483 is dated May 1, 2018.
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.