Ipca Laboratories Limited
FDA inspection history across 3 sites, 2014 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2019: 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 Piparia, India.
- 2014The longest 483 on file: 5 observations over 2 pages at Piparia, India.
- 2019One Form 483, at Silvasa, India.
- 2023One Form 483, at Piparia, Silvassa, India.
Cited most
Across all Ipca Laboratories Limited observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review2
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Ipca Laboratories Limited file.
All 3 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
Piparia, Silvassa, India
One Form 483 · 2023 · 2 observations
Latest: Form 483, Apr 26, 2023 →Silvasa, India
One Form 483 · 2019 · 3 observations
Latest: Form 483, Aug 23, 2019 →Piparia, India
One Form 483 · 2014 · 5 observations
Latest: Form 483, Dec 19, 2014 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-04-26 | 483 Form 483 | Piparia, Silvassa, India | 2 | $99 |
| 2019-08-23 | 483 Form 483 | Silvasa, India | 3 | $99 |
| 2014-12-19 | 483 Form 483 | Piparia, India | 5 | $99 |
Investigators on these documents
Arsen Karapetyan (1)James Maclaughlin (1)Kellia N. Hicks (1)Parul M. Patel (1)Pratik S. Upadhyay (1)Rajiv R. Srivastava (1)
FEI number 3005977675 · most recent document Apr 26, 2023
About Ipca Laboratories Limited
How many FDA Form 483s has Ipca Laboratories Limited received?
FDA Intel has 3 Form 483s on file for Ipca Laboratories Limited; the most recent is dated Apr 26, 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 Apr 26, 2023, for the site in Piparia, Silvassa, 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 211.160 (General requirements), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.194 (Laboratory records), 2 times.