Alkem Laboratories Limited
Form 483 issued July 31, 2015 · Solan, India
- Inspection
- Jul 27 – Jul 31, 2015
- Investigators
- Nicole E. Knowlton· Qin Xu
- Observations
- 3
- Pages
- 2
- FEI number
- 3006370533
In short: On July 31, 2015, FDA issued a Form 483 with 3 observations to Alkem Laboratories Limited in Solan, Himachal Pradesh (FEI 3006370533) after an inspection that ran Jul 27 – Jul 31, 2015. The investigators were Nicole E. Knowlton and Qin Xu. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls 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
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory records do not include a complete record of all data secured in the course of…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the 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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alkem Laboratories Limited?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Alkem Laboratories Limited?
Nicole E. Knowlton and Qin Xu are named on this Form 483, for the inspection of Jul 27 – Jul 31, 2015. Each investigator has a profile showing what they cite most.
When was Alkem Laboratories Limited inspected by FDA?
The inspection ran Jul 27 – Jul 31, 2015, and the Form 483 is dated July 31, 2015.
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.