Biocon Biologics Limited
Form 483 issued April 7, 2017 · Bangalore, India
- Investigators
- Arun Chandavarkar· Kristen Nickens· Lakshmi Naresimban
- Observations
- 1
- Pages
- 6
- FEI number
- 3003981475
In short: On April 7, 2017, FDA issued a Form 483 with 1 observation to Biocon Biologics Limited in Bangalore, India (FEI 3003981475). The investigators were Arun Chandavarkar, Kristen Nickens, Lakshmi Naresimban, Lindsey Brown, Maria Teresa Gutierroz-Lugo, Merry Christie, Michael R. Shanks and Sarah Kennett. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×) · 211.186 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are discrepancies between the information submitted in and the manufacturing process…
This inspection in context
Arun Chandavarkar
1 document · 2017
Cites 211.100 (written procedures; deviations) 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 211.100
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 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Biocon Biologics Limited?
Arun Chandavarkar, Kristen Nickens, Lakshmi Naresimban, Lindsey Brown, Maria Teresa Gutierroz-Lugo, Merry Christie, Michael R. Shanks and Sarah Kennett are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Biocon Biologics Limited inspected by FDA?
This Form 483 is dated April 7, 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.