Alkem Laboratories Ltd
Form 483 issued March 27, 2018 · Daman, India
- Inspection
- Mar 19 – Mar 27, 2018
- Investigators
- Dipesh K. Shah· June P. Page· Kellia N. Hicks
- Observations
- 1
- Pages
- 16
- FEI number
- 3006370524
In short: On March 27, 2018, FDA issued a Form 483 with 1 observation to Alkem Laboratories Ltd in Daman, India (FEI 3006370524) after an inspection that ran Mar 19 – Mar 27, 2018. The investigators were Dipesh K. Shah, June P. Page and Kellia N. Hicks. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
This inspection in context
Dipesh K. Shah
29 documents · 2006–2026
Cites 211.192 (production record review) 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 211.22(a)
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 quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Alkem Laboratories Ltd?
Dipesh K. Shah, June P. Page and Kellia N. Hicks are named on this Form 483, for the inspection of Mar 19 – Mar 27, 2018. Each investigator has a profile showing what they cite most.
When was Alkem Laboratories Ltd inspected by FDA?
The inspection ran Mar 19 – Mar 27, 2018, and the Form 483 is dated March 27, 2018.
How do I get the full Form 483 for Alkem Laboratories Ltd?
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