Biocon Biosphere Limited
Form 483 issued June 14, 2024 · Visakhapatnam, India
- Inspection
- Jun 10 – Jun 14, 2024
- Investigator
- Brandy N. Lepage
- Observations
- 3
- Pages
- 4
- FEI number
- 3022125340
In short: On June 14, 2024, FDA issued a Form 483 with 3 observations to Biocon Biosphere Limited in Visakhapatnam, India (FEI 3022125340) after an inspection that ran Jun 10 – Jun 14, 2024. The investigator was Brandy N. Lepage. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
In-process materials are not tested for identity, strength, quality and pm ity and approved or rejected…
- 03
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 Biosphere Limited history
The site's inspection history, in date order.
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 Biosphere Limited?
FDA listed 3 observations on this Form 483, mostly about production and laboratory controls. 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 Biosphere Limited?
Brandy N. Lepage is named on this Form 483, for the inspection of Jun 10 – Jun 14, 2024. Each investigator has a profile showing what they cite most.
When was Biocon Biosphere Limited inspected by FDA?
The inspection ran Jun 10 – Jun 14, 2024, and the Form 483 is dated June 14, 2024.
How do I get the full Form 483 for Biocon Biosphere 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.