Unichem Laboratories Limited
FDA inspection history in Pilerne, India, 2019 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Pilerne, India.
- 2024One Form 483, at Pilerne, India.
- 2024The longest 483 on file: 5 observations over 8 pages at Pilerne, India.
Cited most
Across all Unichem Laboratories Limited observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.192Production record review1
The complete Unichem Laboratories Limited file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Pilerne, India
Two Form 483s · 2019 to 2024 · 9 observations
Latest: Form 483, Jul 15, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-15 | 483 Form 483 | Pilerne, India | 5 | $99 |
| 2019-07-31 | 483 Form 483 | Pilerne, India | 4 | $99 |
Investigators on these documents
FEI number 3005497507 · most recent document Jul 15, 2024
About Unichem Laboratories Limited
How many FDA Form 483s has Unichem Laboratories Limited received?
FDA Intel has 2 Form 483s on file for Unichem Laboratories Limited; the most recent is dated Jul 15, 2024.
When was Unichem Laboratories Limited last inspected by FDA?
The most recent FDA inspection document on file for Unichem Laboratories Limited is a Form 483 dated Jul 15, 2024, for the site in Pilerne, India.
What did FDA cite at Unichem Laboratories Limited?
The regulations cited most in the observations on file for Unichem Laboratories Limited are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time.