Biocon Biologics Limited

Form 483 issued August 13, 2022 · Bengaluru, India

Inspection: Aug 11 – Aug 13, 2022
Investigators: Arsen Karapetyan· Michael R. Shanks· Ralph M. Bernstein
Observations: 1
Pages: 18
FEI number: 3003981475

In short: On August 13, 2022, FDA issued a Form 483 with 1 observation to Biocon Biologics Limited in Bengaluru, India (FEI 3003981475) after an inspection that ran Aug 11 – Aug 13, 2022. The investigators were Arsen Karapetyan, Michael R. Shanks, Ralph M. Bernstein and Zhong Li.

What FDA observed

Preview: the opening words of each observation

01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…

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This inspection in context

The investigator

Arsen Karapetyan

43 documents · 2014–2025

Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.

The firm

Biocon Biologics Limited history

All 8 documents on file for this site, in date order, with what was cited at each inspection.

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Form 483 from this inspectionAug 26, 2022$99

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Questions about this 483

What did FDA find at Biocon Biologics Limited?

FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.

Who inspected Biocon Biologics Limited?

Arsen Karapetyan, Michael R. Shanks, Ralph M. Bernstein and Zhong Li are named on this Form 483, for the inspection of Aug 11 – Aug 13, 2022. Each investigator has a profile showing what they cite most.

When was Biocon Biologics Limited inspected by FDA?

The inspection ran Aug 11 – Aug 13, 2022, and the Form 483 is dated August 13, 2022.

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.