Biocon Biologics Limited
Form 483 issued February 15, 2019 · Bangalore, India
- Inspection
- Feb 7 – Feb 15, 2019
- Investigators
- Diane Raccasi· Michael R. Shanks
- Observations
- 1
- Pages
- 5
- FEI number
- 3003981475
In short: On February 15, 2019, FDA issued a Form 483 with 1 observation to Biocon Biologics Limited in Bangalore, India (FEI 3003981475) after an inspection that ran Feb 7 – Feb 15, 2019. The investigators were Diane Raccasi and Michael R. Shanks. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
This inspection in context
Diane Raccasi
5 documents · 2015–2019
Cites 211.160 (general requirements) 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 1 observation on this Form 483, mostly about 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?
Diane Raccasi and Michael R. Shanks are named on this Form 483, for the inspection of Feb 7 – Feb 15, 2019. Each investigator has a profile showing what they cite most.
When was Biocon Biologics Limited inspected by FDA?
The inspection ran Feb 7 – Feb 15, 2019, and the Form 483 is dated February 15, 2019.
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.