Unichem Laboratories Limited
FDA inspection history in Pithampur, India, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Pithampur, India.
Cited most
Across all Unichem Laboratories Limited observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Unichem Laboratories Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Pithampur, India
One Form 483 · 2018 · 2 observations
Latest: Form 483, Jul 27, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-07-27 | 483 Form 483 | Pithampur, India | 2 | $99 |
Investigators on these documents
About Unichem Laboratories Limited
How many FDA Form 483s has Unichem Laboratories Limited received?
FDA Intel has 1 Form 483 on file for Unichem Laboratories Limited; the most recent is dated Jul 27, 2018.
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 27, 2018, for the site in Pithampur, 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 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.