Claris Injectables Limited Chacharwadi Vasna
FDA inspection history across 2 sites, 2010 to 2023
- 5
- Form 483s
- 2
- Warning letters
- 2
- Close-outs
Every document, by year
- Warning letter
- Form 483
- Close-out
2010: one warning letter; 2012: one close-out letter; 2016: one Form 483; 2017: two Form 483s; 2018: one close-out letter; 2022: 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.
- 2010–12One warning letter and one close-out letter.
- 2016–18Three Form 483s and one close-out letter, at Ahmedabad, India.
- 2022–23Two Form 483s and one warning letter, at Ahmedabad, India and Deerfield, Illinois.
- 2023The longest 483 on file: 9 observations over 19 pages at Ahmedabad, India.
Cited most
Across all Claris Injectables Limited Chacharwadi Vasna observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review2
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
The complete Claris Injectables Limited Chacharwadi Vasna file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Ahmedabad, India
Five Form 483s · 2016 to 2023 · 19 observations
Latest: Form 483, Jan 27, 2023 →Deerfield, Illinois
One warning letter · 2023
Latest: Warning letter, Jul 25, 2023 →
Also: three documents not tied to a site.
Documents
9 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-25 | Warning letter Warning letter | Deerfield, Illinois | — | $99 |
| 2023-01-27 | 483 Form 483 | Ahmedabad, India | 9 | $99 |
| 2022-05-17 | 483 Form 483 | Ahmedabad, India | 7 | $99 |
| 2018-07-05 | Close-out Close-out letter | — | — | $99 |
| 2017-08-04 | 483 Form 483 | Ahmedabad, India | 1 | $99 |
| 2017-07-27 | 483 Form 483 | Ahmedabad, India | 1 | $99 |
| 2016-08-26 | 483 Form 483 | Ahmedabad, India | 1 | $99 |
| 2012-08-14 | Close-out Close-out letter | — | — | $99 |
| 2010-11-01 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
Massoud Motamed (2)Anastasia M. Shields (2)Th J. Arista (2)Pratik S. Upadhyay (1)Justin A. Boyd (1)Angela E. Glenn (1)Jose E. Melendez (1)
FEI number 3004610460 · most recent document Jul 25, 2023
About Claris Injectables Limited Chacharwadi Vasna
How many FDA Form 483s has Claris Injectables Limited Chacharwadi Vasna received?
FDA Intel has 5 Form 483s on file for Claris Injectables Limited Chacharwadi Vasna; the most recent is dated Jan 27, 2023.
When was Claris Injectables Limited Chacharwadi Vasna last inspected by FDA?
The most recent FDA inspection document on file for Claris Injectables Limited Chacharwadi Vasna is a Form 483 dated Jan 27, 2023, for the site in Ahmedabad, India.
What did FDA cite at Claris Injectables Limited Chacharwadi Vasna?
The regulations cited most in the observations on file for Claris Injectables Limited Chacharwadi Vasna are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.192 (Production record review), 2 times.
Has Claris Injectables Limited Chacharwadi Vasna received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Claris Injectables Limited Chacharwadi Vasna; the most recent is dated Jul 25, 2023.