FEI 3005029956
FDA inspection history across 2 sites, 2017 to 2024
- 4
- Form 483s
- 2
- Close-outs
Every document, by year
- Close-out
- Form 483
2017: one Form 483; 2019: one close-out letter and one Form 483; 2022: one Form 483; 2024: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s and one close-out letter, at Indrad, India and Ahmedabad, India.
- 2022–24Two Form 483s and one close-out letter, at Indrad, India.
- 2022The longest 483 on file: 3 observations over 15 pages at Indrad, India.
Cited most
Across all site observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.198(b)(2)Complaint files1
The complete site file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Indrad, India
Four Form 483s and one close-out letter · 2017 to 2024 · 8 observations
Latest: Close-out, Sep 4, 2024 →Ahmedabad, India
One close-out letter · 2019
Latest: Close-out, Oct 8, 2019 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-09-04 | Close-out Close-out letter | Indrad, India | — | $99 |
| 2024-06-12 | 483 Form 483 | Indrad, India | 3 | $99 |
| 2022-09-28 | 483 Form 483 | Indrad, India | 3 | $99 |
| 2019-10-08 | Close-out Close-out letter | Ahmedabad, India | — | $99 |
| 2019-04-16 | 483 Form 483 | Indrad, India | 1 | $99 |
| 2017-04-28 | 483 Form 483 | Indrad, India | 1 | $99 |
Investigators on these documents
Djamila Harouaka (1)Gam S. Zamil (1)Lata Mathew (1)Pratik S. Upadhyay (1)Steven A. Brettler (1)Zhao Wang (1)
FEI number 3005029956 · most recent document Sep 4, 2024
About FEI 3005029956
How many FDA Form 483s has FEI 3005029956 received?
FDA Intel has 4 Form 483s on file for FEI 3005029956; the most recent is dated Jun 12, 2024.
When was FEI 3005029956 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3005029956 is a Form 483 dated Jun 12, 2024, for the site in Indrad, India.
What did FDA cite at FEI 3005029956?
The regulations cited most in the observations on file for FEI 3005029956 are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.