Overview
- 16 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-15.
At a glance
Inspections
16
Form 483s
4
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Nov 2024 – 15 Nov 2024 | Human Drugs | Clean | |
| 22 Jan 2024 – 25 Jan 2024 | Human Drugs | Clean | |
| 26 Mar 2018 – 29 Mar 2018 | Human Drugs | Clean | |
| 1 Feb 2018 – 15 Feb 2018 | Human Drugs | 483 | View 483 → |
| 9 Jan 2017 – 26 Jan 2017 | Human Drugs | 483 | View 483 → |
| 7 Nov 2013 – 19 Nov 2013 | Human Drugs | Clean | |
| 12 Jan 2012 | Not recorded | Clean | |
| 15 Apr 2011 | Not recorded | Clean | |
| 17 May 2010 | Not recorded | 483 | View 483 → |
| 18 Jun 2009 | Not recorded | 483 | View 483 → |
| 20 Dec 2007 | Not recorded | Clean | |
| 21 Dec 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Feb 2018
21 CFR 211.100(b)
Procedure Deviations Recorded and Justified
Cited by Tamil Arasu, William R Chang, Yvins Dezan
15 Feb 2018
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Tamil Arasu, William R Chang, Yvins Dezan
15 Feb 2018
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Tamil Arasu, William R Chang, Yvins Dezan
15 Feb 2018
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Tamil Arasu, William R Chang, Yvins Dezan
15 Feb 2018
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Tamil Arasu, William R Chang, Yvins Dezan
Investigators
FDA investigators tied to this site in the record.
Nicholas A Violand3 insp.
Paul L Bellamy2 insp.
Barbara J Wilimczyk-Macri2 insp.
Erin D Mccaffery2 insp.
Nicola M Fenty-Stewart1 insp.
Li-Hong P Yeh1 insp.
Mayar M Mussa1 insp.
Michael Serrano1 insp.
Tamil Arasu1 insp.
William R Chang1 insp.
Yvins Dezan1 insp.
Adetutu M Gidado1 insp.
Laura Fontan1 insp.
Frederick Razzaghi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(c)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.134(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cosette Pharmaceuticals, Inc.'s 4 Form 483s
Source PDFs, verbatim observations, and 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