CTX Lifesciences Private Ltd
FDA inspection history in Surat, India, 2016 to 2023
- 4
- Close-outs
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2016: one Form 483; 2017: one warning letter; 2018: two close-out letters; 2019: one close-out letter and one Form 483; 2023: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19Three close-out letters, two Form 483s and one warning letter, at Surat, India.
- 2016The longest 483 on file: 6 observations over 7 pages at Surat, India.
- 2023One close-out letter.
Cited most
Across all CTX Lifesciences Private observations on file
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.192Production record review2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.125Labeling issuance1
The complete CTX Lifesciences Private file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Surat, India
Two Form 483s · 2016 to 2019 · 10 observations
Latest: Form 483, Feb 16, 2019 →
Also: five documents not tied to a site.
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-11 | Close-out Close-out letter | — | — | $99 |
| 2019-07-12 | Close-out Close-out letter | — | — | $99 |
| 2019-02-16 | 483 Form 483 | Surat, India | 4 | $99 |
| 2018-10-05 | Close-out Close-out letter | — | — | $99 |
| 2018-10-05 | Close-out Close-out letter | — | — | $99 |
| 2017-01-18 | Warning letter Warning letter | — | — | $99 |
| 2016-02-18 | 483 Form 483 | Surat, India | 6 | $99 |
Investigators on these documents
FEI number 3006254924 · most recent document Jan 11, 2023
About CTX Lifesciences Private Ltd
How many FDA Form 483s has CTX Lifesciences Private Ltd received?
FDA Intel has 2 Form 483s on file for CTX Lifesciences Private Ltd; the most recent is dated Feb 16, 2019.
When was CTX Lifesciences Private Ltd last inspected by FDA?
The most recent FDA inspection document on file for CTX Lifesciences Private Ltd is a Form 483 dated Feb 16, 2019, for the site in Surat, India.
What did FDA cite at CTX Lifesciences Private Ltd?
The regulations cited most in the observations on file for CTX Lifesciences Private Ltd are 21 CFR 211.22 (Responsibilities of quality control unit), 3 times; 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.192 (Production record review), 2 times.
Has CTX Lifesciences Private Ltd received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for CTX Lifesciences Private Ltd; the most recent is dated Jan 18, 2017.