Ipca Laboratories Limited
FDA inspection history across 2 sites, 2014 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at Indore, India.
- 2023One Form 483, at Dhar, India.
- 2023The longest 483 on file: 8 observations over 18 pages at Dhar, India.
Cited most
Across all Ipca Laboratories Limited observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.111Time limitations on production1
The complete Ipca 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
Dhar, India
One Form 483 · 2023 · 8 observations
Latest: Form 483, Jun 23, 2023 →Indore, India
One Form 483 · 2014 · 6 observations
Latest: Form 483, Oct 17, 2014 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-23 | 483 Form 483 | Dhar, India | 8 | $99 |
| 2014-10-17 | 483 Form 483 | Indore, India | 6 | $99 |
Investigators on these documents
Peter E. Baker (1)Rajiv R. Srivastava (1)Saleem A. Akhtar (1)Wenzheng Zhang (1)
FEI number 3007574780 · most recent document Jun 23, 2023
About Ipca Laboratories Limited
How many FDA Form 483s has Ipca Laboratories Limited received?
FDA Intel has 2 Form 483s on file for Ipca Laboratories Limited; the most recent is dated Jun 23, 2023.
When was Ipca Laboratories Limited last inspected by FDA?
The most recent FDA inspection document on file for Ipca Laboratories Limited is a Form 483 dated Jun 23, 2023, for the site in Dhar, India.
What did FDA cite at Ipca Laboratories Limited?
The regulations cited most in the observations on file for Ipca Laboratories Limited are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.194 (Laboratory records), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.