Intas Pharmaceuticals Ltd.
FDA inspection history in Ahmedabad, India, 2017 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Ahmedabad, India.
- 2017The longest 483 on file: 14 observations over 16 pages at Ahmedabad, India.
- 2022–23Two Form 483s, at Ahmedabad, India.
Cited most
Across all Intas Pharmaceuticals observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.160General requirements5
- 21 CFR 211.194Laboratory records4
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.192Production record review3
The complete Intas Pharmaceuticals 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
Ahmedabad, India
Three Form 483s · 2017 to 2023 · 30 observations
Latest: Form 483, Dec 7, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-07 | 483 Form 483 | Ahmedabad, India | 7 | $99 |
| 2022-08-09 | 483 Form 483 | Ahmedabad, India | 9 | $99 |
| 2017-05-10 | 483 Form 483 | Ahmedabad, India | 14 | $99 |
Investigators on these documents
Aditi S. Thakur (1)Arsen Karapetyan (1)Bijoy Panicker (1)Daniel J. Roberts (1)Hyung Lee (1)Jeanne Fringer (1)Massod Rahimi (1)Michael R. Shanks (1)Patric C. Klotzbuecher (1)Thuy T. Nguyen (1)Zhong Li (1)
FEI number 3007277149 · most recent document Dec 7, 2023
About Intas Pharmaceuticals Ltd.
How many FDA Form 483s has Intas Pharmaceuticals Ltd. received?
FDA Intel has 3 Form 483s on file for Intas Pharmaceuticals Ltd.; the most recent is dated Dec 7, 2023.
When was Intas Pharmaceuticals Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Intas Pharmaceuticals Ltd. is a Form 483 dated Dec 7, 2023, for the site in Ahmedabad, India.
What did FDA cite at Intas Pharmaceuticals Ltd.?
The regulations cited most in the observations on file for Intas Pharmaceuticals Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.160 (General requirements), 5 times; 21 CFR 211.194 (Laboratory records), 4 times.