Ipca Laboratories Limited 1/29/16
FDA inspection history in Ratlam, India, 2014 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one Form 483; 2016: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16One Form 483 and one warning letter, at Ratlam, India.
- 2023One Form 483, at Ratlam, India.
- 2023The longest 483 on file: 6 observations over 18 pages at Ratlam, India.
Cited most
Across all Ipca Laboratories Limited 1/29/16 observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.160General requirements2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 111
The complete Ipca Laboratories Limited 1/29/16 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
Ratlam, India
Two Form 483s and one warning letter · 2014 to 2023 · 12 observations
Latest: Form 483, Jun 13, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-06-13 | 483 Form 483 | Ratlam, India | 6 | $99 |
| 2016-01-29 | Warning letter Warning letter | Ratlam, India | — | $99 |
| 2014-07-18 | 483 Form 483 | Ratlam, India | 6 | $99 |
Investigators on these documents
Joanne E. King (1)Peter E. Baker (1)Rajiv R. Srivastava (1)Saleem A. Akhtar (1)Wenzheng Zhang (1)
FEI number 3002807297 · most recent document Jun 13, 2023
About Ipca Laboratories Limited 1/29/16
How many FDA Form 483s has Ipca Laboratories Limited 1/29/16 received?
FDA Intel has 2 Form 483s on file for Ipca Laboratories Limited 1/29/16; the most recent is dated Jun 13, 2023.
When was Ipca Laboratories Limited 1/29/16 last inspected by FDA?
The most recent FDA inspection document on file for Ipca Laboratories Limited 1/29/16 is a Form 483 dated Jun 13, 2023, for the site in Ratlam, India.
What did FDA cite at Ipca Laboratories Limited 1/29/16?
The regulations cited most in the observations on file for Ipca Laboratories Limited 1/29/16 are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.166 (Stability testing), 2 times.
Has Ipca Laboratories Limited 1/29/16 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Ipca Laboratories Limited 1/29/16; the most recent is dated Jan 29, 2016.