Anthea Pharma Private Limited
Form 483 issued July 5, 2024 · Sangareddy, India
- Inspection
- Jun 27 – Jul 5, 2024
- Observations
- 3
- Pages
- 5
- FEI number
- 3026048557
In short: On July 5, 2024, FDA issued a Form 483 with 3 observations to Anthea Pharma Private Limited in Sangareddy, Telangana (FEI 3026048557) after an inspection that ran Jun 27 – Jul 5, 2024. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Batch production and control records do not include the results of any investigation made into any…
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 laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
When was Anthea Pharma Private Limited inspected by FDA?
The inspection ran Jun 27 – Jul 5, 2024, and the Form 483 is dated July 5, 2024.
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.