Alembic Pharmaceuticals Limited
Form 483 issued November 22, 2024 · Jarod, India
- Inspection
- Nov 14 – Nov 22, 2024
- Investigator
- Teresa I. Navas
- Observations
- 5
- Pages
- 5
- FEI number
- 3016088083
In short: On November 22, 2024, FDA issued a Form 483 with 5 observations to Alembic Pharmaceuticals Limited in Jarod, Gujarat (FEI 3016088083) after an inspection that ran Nov 14 – Nov 22, 2024. The investigator was Teresa I. Navas. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for…
- 04
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
This inspection in context
Teresa I. Navas
21 documents · 2020–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAlembic Pharmaceuticals Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alembic Pharmaceuticals Limited?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. 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.
Who inspected Alembic Pharmaceuticals Limited?
Teresa I. Navas is named on this Form 483, for the inspection of Nov 14 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was Alembic Pharmaceuticals Limited inspected by FDA?
The inspection ran Nov 14 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for Alembic Pharmaceuticals 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.