Cohance Lifesciences Limited
FDA inspection history across 3 sites, 2019 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Medchal-Malkajgiri, India.
- 2025–26One Form 483 and one warning letter, at Secunderabad, India and Hyderabad, India.
- 2025The longest 483 on file: 6 observations over 17 pages at Secunderabad, India.
Cited most
Across all Cohance Lifesciences Limited observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.192Production record review1
The complete Cohance Lifesciences Limited 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
Hyderabad, India
One warning letter · 2026
Latest: Warning letter, Jan 30, 2026 →Secunderabad, India
One Form 483 · 2025 · 6 observations
Latest: Form 483, Aug 12, 2025 →Medchal-Malkajgiri, India
One Form 483 · 2019 · 3 observations
Latest: Form 483, Aug 20, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-01-30 | Warning letter Warning letter | Hyderabad, India | — | $99 |
| 2025-08-12 | 483 Form 483 | Secunderabad, India | 6 | $99 |
| 2019-08-20 | 483 Form 483 | Medchal-Malkajgiri, India | 3 | $99 |
Investigators on these documents
FEI number 3008768274 · most recent document Jan 30, 2026
About Cohance Lifesciences Limited
How many FDA Form 483s has Cohance Lifesciences Limited received?
FDA Intel has 2 Form 483s on file for Cohance Lifesciences Limited; the most recent is dated Aug 12, 2025.
When was Cohance Lifesciences Limited last inspected by FDA?
The most recent FDA inspection document on file for Cohance Lifesciences Limited is a Form 483 dated Aug 12, 2025, for the site in Secunderabad, India.
What did FDA cite at Cohance Lifesciences Limited?
The regulations cited most in the observations on file for Cohance Lifesciences Limited are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.160(b) (General requirements), 1 time.
Has Cohance Lifesciences Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Cohance Lifesciences Limited; the most recent is dated Jan 30, 2026.