Intas Pharmaceuticals Limited
FDA inspection history in Ahmedabad, India, 2019 to 2023
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2020: one Form 483; 2022: two Form 483s; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–23Four Form 483s and one warning letter, at Ahmedabad, India.
- 2022The longest 483 on file: 11 observations over 36 pages at Ahmedabad, India.
Cited most
Across all Intas Pharmaceuticals Limited observations on file
- 21 CFR 211.192Production record review6
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.113Control of microbiological contamination2
The complete Intas Pharmaceuticals Limited file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Ahmedabad, India
Four Form 483s · 2019 to 2022 · 30 observations
Latest: Form 483, Dec 2, 2022 →
Also: one document not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-28 | Warning letter Warning letter | — | — | $99 |
| 2022-12-02 | 483 Form 483 | Ahmedabad, India | 11 | $99 |
| 2022-02-02 | 483 Form 483 | Ahmedabad, India | 11 | $99 |
| 2020-02-28 | 483 Form 483 | Ahmedabad, India | 1 | $99 |
| 2019-05-28 | 483 Form 483 | Ahmedabad, India | 7 | $99 |
Investigators on these documents
Jose E. Melendez (2)Justin A. Boyd (2)Pratik S. Upadhyay (2)Jennifer L. Huntington (1)Patric C. Klotzbuecher (1)
FEI number 3004011473 · most recent document Jul 28, 2023
About Intas Pharmaceuticals Limited
How many FDA Form 483s has Intas Pharmaceuticals Limited received?
FDA Intel has 4 Form 483s on file for Intas Pharmaceuticals Limited; the most recent is dated Dec 2, 2022.
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 Dec 2, 2022, 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 211.192 (Production record review), 6 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 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 Jul 28, 2023.