CiplaLtd
FDA inspection history across 2 sites, 2018 to 2024
- 4
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2019: one Form 483; 2024: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Pune, India.
- 2019The longest 483 on file: 18 observations over 15 pages at Pune, India.
- 2024Two Form 483s, at Pune, India and Kurkumbh, India.
Cited most
Across all CiplaLtd observations on file
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.160General requirements2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.166Stability testing1
The complete CiplaLtd file.
All 4 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
Pune, India
Three Form 483s · 2018 to 2024 · 21 observations
Latest: Form 483, May 8, 2024 →Kurkumbh, India
One Form 483 · 2024 · 1 observation
Latest: Form 483, May 3, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-08 | 483 Form 483 | Pune, India | 1 | $99 |
| 2024-05-03 | 483 Form 483 | Kurkumbh, India | 1 | $99 |
| 2019-03-20 | 483 Form 483 | Pune, India | 18 | $99 |
| 2018-11-30 | 483 Form 483 | Pune, India | 2 | $99 |
Investigators on these documents
Haitao Li (2)Santos E. Camara (2)Angela E. Glenn (1)Cheryl Clausen (1)Rozelle G. Smith (1)Vani Mathur Richards (1)
FEI number 3002806702 · most recent document May 8, 2024
About CiplaLtd
How many FDA Form 483s has CiplaLtd received?
FDA Intel has 4 Form 483s on file for CiplaLtd; the most recent is dated May 8, 2024.
When was CiplaLtd last inspected by FDA?
The most recent FDA inspection document on file for CiplaLtd is a Form 483 dated May 8, 2024, for the site in Pune, India.
What did FDA cite at CiplaLtd?
The regulations cited most in the observations on file for CiplaLtd are 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 2 times.