Unichem Laboratories Limited
Form 483 issued July 15, 2024 · Pilerne, India
- Inspection
- Jul 8 – Jul 15, 2024
- Investigators
- Saleem A. Akhtar· Wayne D. McGrath
- Observations
- 5
- Pages
- 8
- FEI number
- 3005497507
In short: On July 15, 2024, FDA issued a Form 483 with 5 observations to Unichem Laboratories Limited in Pilerne, Goa (FEI 3005497507) after an inspection that ran Jul 8 – Jul 15, 2024. The investigators were Saleem A. Akhtar and Wayne D. McGrath. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Written production and process control procedures are not followed in the execution of production and. process…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmUnichem Laboratories Limited history
All 2 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 Unichem Laboratories Limited?
FDA listed 5 observations on this Form 483, mostly about quality system, production and facilities & equipment. 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 Unichem Laboratories Limited?
Saleem A. Akhtar and Wayne D. McGrath are named on this Form 483, for the inspection of Jul 8 – Jul 15, 2024. Each investigator has a profile showing what they cite most.
When was Unichem Laboratories Limited inspected by FDA?
The inspection ran Jul 8 – Jul 15, 2024, and the Form 483 is dated July 15, 2024.
How do I get the full Form 483 for Unichem Laboratories Limited?
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