Alkem Laboratories Limited
Form 483 issued March 10, 2017 · Baddi, India
- Inspection
- Mar 2 – Mar 10, 2017
- Investigators
- Maria E. Estrella· Nicole E. Knowlton
- Observations
- 2
- Pages
- 2
- FEI number
- 3006370533
In short: On March 10, 2017, FDA issued a Form 483 with 2 observations to Alkem Laboratories Limited in Baddi, India (FEI 3006370533) after an inspection that ran Mar 2 – Mar 10, 2017. The investigators were Maria E. Estrella and Nicole E. Knowlton. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and production account for 2 of 2 observations.
Most cited: 21 CFR 211.166 (1×) · 211.186 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written testing stability…
- 02
Master production and control records lack complete manufacturing and control…
This inspection in context
Maria E. Estrella
6 documents · 2017–2026
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in India.
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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alkem Laboratories Limited?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Alkem Laboratories Limited?
Maria E. Estrella and Nicole E. Knowlton are named on this Form 483, for the inspection of Mar 2 – Mar 10, 2017. Each investigator has a profile showing what they cite most.
When was Alkem Laboratories Limited inspected by FDA?
The inspection ran Mar 2 – Mar 10, 2017, and the Form 483 is dated March 10, 2017.
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.