Alkem Laboratories Limited
Form 483 issued February 21, 2020 · Baddi, India
- Inspection
- Feb 17 – Feb 21, 2020
- Observations
- 2
- Pages
- 2
- FEI number
- 3006370533
In short: On February 21, 2020, FDA issued a Form 483 with 2 observations to Alkem Laboratories Limited in Baddi, Himachal Pradesh (FEI 3006370533) after an inspection that ran Feb 17 – Feb 21, 2020. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.63 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Written records are not always made of investigations into the failure of a batch or any…
This inspection in context
Questions about this 483
What did FDA find at Alkem Laboratories Limited?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
When was Alkem Laboratories Limited inspected by FDA?
The inspection ran Feb 17 – Feb 21, 2020, and the Form 483 is dated February 21, 2020.
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.