Biocon Limited
Form 483 issued June 21, 2024 · Anakapalli, India
- Inspection
- Jun 17 – Jun 21, 2024
- Investigator
- Brandy N. Lepage
- Observations
- 4
- Pages
- 3
- FEI number
- 3006400591
In short: On June 21, 2024, FDA issued a Form 483 with 4 observations to Biocon Limited in Anakapalli, Andhra Pradesh (FEI 3006400591) after an inspection that ran Jun 17 – Jun 21, 2024. The investigator was Brandy N. Lepage. Most observations concern facilities & equipment and quality system.
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmBiocon Limited history
The site's inspection history, in date order.
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 4 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Biocon Limited?
Brandy N. Lepage is named on this Form 483, for the inspection of Jun 17 – Jun 21, 2024. Each investigator has a profile showing what they cite most.
When was Biocon Limited inspected by FDA?
The inspection ran Jun 17 – Jun 21, 2024, and the Form 483 is dated June 21, 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.