Alkem Laboratories Limited
Form 483 issued March 27, 2024 · Baddi, India
- Inspection
- Mar 19 – Mar 27, 2024
- Investigators
- Nicole E. Knowlton· Yvins Dezan
- Observations
- 1
- Pages
- 17
- FEI number
- 3006370533
In short: On March 27, 2024, FDA issued a Form 483 with 1 observation to Alkem Laboratories Limited in Baddi, India (FEI 3006370533) after an inspection that ran Mar 19 – Mar 27, 2024. The investigators were Nicole E. Knowlton and Yvins Dezan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmAlkem Laboratories Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alkem Laboratories Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Alkem Laboratories Limited?
Nicole E. Knowlton and Yvins Dezan are named on this Form 483, for the inspection of Mar 19 – Mar 27, 2024. Each investigator has a profile showing what they cite most.
When was Alkem Laboratories Limited inspected by FDA?
The inspection ran Mar 19 – Mar 27, 2024, and the Form 483 is dated March 27, 2024.
How do I get the full Form 483 for Alkem Laboratories 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.