Alkem Laboratories Ltd
Form 483 issued September 29, 2016 · Daman, India
- Inspection
- Sep 20 – Sep 29, 2016
- Investigators
- Cheryl Clausen· Tiara N. Brown-Crosen
- Observations
- 1
- Pages
- 11
- FEI number
- 3006370524
In short: On September 29, 2016, FDA issued a Form 483 with 1 observation to Alkem Laboratories Ltd in Daman, India (FEI 3006370524) after an inspection that ran Sep 20 – Sep 29, 2016. The investigators were Cheryl Clausen and Tiara N. Brown-Crosen. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Cheryl Clausen
18 documents · 2016–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmAlkem Laboratories Ltd history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alkem Laboratories Ltd?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Alkem Laboratories Ltd?
Cheryl Clausen and Tiara N. Brown-Crosen are named on this Form 483, for the inspection of Sep 20 – Sep 29, 2016. Each investigator has a profile showing what they cite most.
When was Alkem Laboratories Ltd inspected by FDA?
The inspection ran Sep 20 – Sep 29, 2016, and the Form 483 is dated September 29, 2016.
How do I get the full Form 483 for Alkem Laboratories Ltd?
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.