Biocon Limited
Form 483 issued January 24, 2020 · Bommasandra Post, India
- Inspection
- Jan 20 – Jan 24, 2020
- Investigator
- Marcellinus D. Dordunoo
- Observations
- 5
- Pages
- 4
- FEI number
- 3010164491
In short: On January 24, 2020, FDA issued a Form 483 with 5 observations to Biocon Limited in Bommasandra Post, Bangalore (FEI 3010164491) after an inspection that ran Jan 20 – Jan 24, 2020. The investigator was Marcellinus D. Dordunoo. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Cleaning Validation Protocols designed to assess potential product-to-product carryover in non-dedicated…
- 02
Failure to perfonn adequately…
- 03
Equipment used in production operations…
- 04
Failure to fulfil the responsibilities of…
This inspection in context
Marcellinus D. Dordunoo
21 documents · 2017–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Maryland.
The firmBiocon Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biocon Limited?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Biocon Limited?
Marcellinus D. Dordunoo is named on this Form 483, for the inspection of Jan 20 – Jan 24, 2020. Each investigator has a profile showing what they cite most.
When was Biocon Limited inspected by FDA?
The inspection ran Jan 20 – Jan 24, 2020, and the Form 483 is dated January 24, 2020.
How do I get the full Form 483 for Biocon 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.