Biocon Biologics Limited
Form 483 issued September 19, 2019 · Bengaluru, India
- Inspection
- Sep 13 – Sep 19, 2019
- Investigators
- Richard Ledwidge· Scott R. Nichols· Steven Fong
- Observations
- 8
- Pages
- 3
- FEI number
- 3003981475
In short: On September 19, 2019, FDA issued a Form 483 with 8 observations to Biocon Biologics Limited in Bengaluru, Karnataka (FEI 3003981475) after an inspection that ran Sep 13 – Sep 19, 2019. The investigators were Richard Ledwidge, Scott R. Nichols and Steven Fong. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 3 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(b)(4) Root cause investigations of out of specification results in the manufacture of (b)(4)…
- 02
Corrective and preventative actions for microbial…
- 03
Equipment used in the manufacture of (b)(4) drug substance…
- 04
The equipment maintenance program of the (b)(4) facility is not adequate to prevent malfunction of equipment…
This inspection in context
Richard Ledwidge
18 documents · 2015–2024
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 8 observations on this Form 483, mostly about quality system, facilities & equipment 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?
Richard Ledwidge, Scott R. Nichols and Steven Fong are named on this Form 483, for the inspection of Sep 13 – Sep 19, 2019. Each investigator has a profile showing what they cite most.
When was Biocon Biologics Limited inspected by FDA?
The inspection ran Sep 13 – Sep 19, 2019, and the Form 483 is dated September 19, 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.