Anthea Pharma Private Limited
Form 483 issued April 4, 2025 · Sangareddy, India
- Observations
- 3
- Pages
- 6
- FEI number
- 3026048557
In short: On April 4, 2025, FDA issued a Form 483 with 3 observations to Anthea Pharma Private Limited in Sangareddy, Telangana (FEI 3026048557). Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
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
Drug products failing to meet established specifications and quality control…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Questions about this 483
What did FDA find at Anthea Pharma Private Limited?
FDA listed 3 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
When was Anthea Pharma Private Limited inspected by FDA?
This Form 483 is dated April 4, 2025.
How do I get the full Form 483 for Anthea 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.