Intas Pharmaceuticals Limited
FDA inspection history in Ahmedabad, India, 2017 to 2023
- 6
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2017: two Form 483s; 2018: two Form 483s; 2019: one Form 483; 2023: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Five Form 483s, at Ahmedabad, India.
- 2023One warning letter and one Form 483, at Ahmedabad, India.
- 2023The longest 483 on file: 16 observations over 29 pages at Ahmedabad, India.
Cited most
Across all Intas Pharmaceuticals Limited observations on file
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160(b)General requirements2
The complete Intas Pharmaceuticals Limited file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Ahmedabad, India
Six Form 483s and one warning letter · 2017 to 2023 · 36 observations
Latest: Warning letter, Nov 21, 2023 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-11-21 | Warning letter Warning letter | Ahmedabad, India | — | $99 |
| 2023-05-12 | 483 Form 483 | Ahmedabad, India | 16 | $99 |
| 2019-08-02 | 483 Form 483 | Ahmedabad, India | 14 | $99 |
| 2018-12-14 | 483 Form 483 | Ahmedabad, India | 1 | $99 |
| 2018-06-08 | 483 Form 483 | Ahmedabad, India | 2 | $99 |
| 2017-07-31 | 483 Form 483 | Ahmedabad, India | 1 | $99 |
| 2017-02-17 | 483 Form 483 | Ahmedabad, India | 2 | $99 |
Investigators on these documents
Arsen Karapetyan (1)Justin A. Boyd (1)Matthew B. Casale (1)Rita K. Kabaso (1)Unnee Ranjan (1)Vilmary Negron Rodriguez (1)Yasamin Ameri (1)
FEI number 3003157498 · most recent document Nov 21, 2023
About Intas Pharmaceuticals Limited
How many FDA Form 483s has Intas Pharmaceuticals Limited received?
FDA Intel has 6 Form 483s on file for Intas Pharmaceuticals Limited; the most recent is dated May 12, 2023.
When was Intas Pharmaceuticals Limited last inspected by FDA?
The most recent FDA inspection document on file for Intas Pharmaceuticals Limited is a Form 483 dated May 12, 2023, for the site in Ahmedabad, India.
What did FDA cite at Intas Pharmaceuticals Limited?
The regulations cited most in the observations on file for Intas Pharmaceuticals Limited are 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times.
Has Intas Pharmaceuticals Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Intas Pharmaceuticals Limited; the most recent is dated Nov 21, 2023.