Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-01-26.
At a glance
Inspections
6
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Jan 2023 – 26 Jan 2023 | Human Drugs | Clean | |
| 11 Nov 2019 – 15 Nov 2019 | Human Drugs | Clean | |
| 22 Apr 2019 – 26 Apr 2019 | Human Drugs | Clean | |
| 18 Sep 2017 – 22 Sep 2017 | Human Drugs | Clean | |
| 1 Aug 2016 – 5 Aug 2016 | Human Drugs | 483 | View 483 → |
| 15 Jun 2015 – 19 Jun 2015 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Aug 2016
21 CFR 812.110(b)
Investigator non-compliance with agreement/plan/regulations
Cited by Janete F Guardia
Investigators
FDA investigators tied to this site in the record.
Janete F Guardia2 insp.
Dawn C Olenjack1 insp.
Amanda Lewin1 insp.
Gajendiran Mahadevan1 insp.
Li-Hong Yeh1 insp.
Ruben C Ayala1 insp.
Joanne M Schlossin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.110(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cohance Lifesciences Limited's 1 Form 483
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat