Biocon Limited
Form 483 issued September 27, 2024 · Bengaluru, India
- Inspection
- Sep 23 – Sep 27, 2024
- Investigator
- Hung H. Do
- Observations
- 4
- Pages
- 11
- FEI number
- 3010164491
In short: On September 27, 2024, FDA issued a Form 483 with 4 observations to Biocon Limited in Bengaluru, Karnataka (FEI 3010164491) after an inspection that ran Sep 23 – Sep 27, 2024. The investigator was Hung H. Do. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your quality unit (QU) failed to adequately implement the API facility’s quality function…
- 02
The lack of sufficient controls over computerized systems undermined the integrity…
- 03
Cleaning validation protocols designed to assess potential product-to-product carryover in non-dedicated…
- 04
Established procedures in your master batch manufacturing records (BMRs) are not scientifically and logically written to…
This inspection in context
Hung H. Do
11 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biocon Limited?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Biocon Limited?
Hung H. Do is named on this Form 483, for the inspection of Sep 23 – Sep 27, 2024. Each investigator has a profile showing what they cite most.
When was Biocon Limited inspected by FDA?
The inspection ran Sep 23 – Sep 27, 2024, and the Form 483 is dated September 27, 2024.
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.