Apitoria Pharma Private Limited
Form 483 issued December 17, 2024 · Sangareddy, India
- Inspection
- Dec 9 – Dec 17, 2024
- Investigator
- Bijoy Panicker
- Observations
- 2
- Pages
- 3
- FEI number
- 3004051616
In short: On December 17, 2024, FDA issued a Form 483 with 2 observations to Apitoria Pharma Private Limited in Sangareddy, Telangana (FEI 3004051616) after an inspection that ran Dec 9 – Dec 17, 2024. The investigator was Bijoy Panicker. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug substances purporting to be sterile did not include…
- 02
Reserve samples from representative sample lots or batches of drug substances selected by acceptable statistical procedures…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmApitoria Pharma Private Limited history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apitoria Pharma Private Limited?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Apitoria Pharma Private Limited?
Bijoy Panicker is named on this Form 483, for the inspection of Dec 9 – Dec 17, 2024. Each investigator has a profile showing what they cite most.
When was Apitoria Pharma Private Limited inspected by FDA?
The inspection ran Dec 9 – Dec 17, 2024, and the Form 483 is dated December 17, 2024.
How do I get the full Form 483 for Apitoria Pharma Private 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.