Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-12.
At a glance
Inspections
8
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Sep 2025 – 12 Sep 2025 | Human Drugs | 483 | View 483 → |
| 18 Jul 2022 – 22 Jul 2022 | Human Drugs | 483 | View 483 → |
| 14 Sep 2017 – 20 Sep 2017 | Human Drugs | 483 | On file |
| 15 Dec 2014 – 22 Dec 2014 | Human Drugs | 483 | On file |
| 13 Dec 2012 | Not recorded | 483 | View 483 → |
| 19 Jul 2010 | Not recorded | 483 | View 483 → |
| 26 Mar 2008 | Not recorded | Clean | |
| 31 Mar 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
22 Jul 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Joohi Castelvetere, Jacob G Lutz
13 Dec 2012
21 CFR 211.68(b)
Backup data not assured as exact and complete
Cited by Barbara J Wilimczyk-Macri
Investigators
FDA investigators tied to this site in the record.
Christian F Gomez Lugo1 insp.
Joohi Castelvetere1 insp.
Jacob G Lutz1 insp.
Tamil Arasu1 insp.
Frederick Razzaghi1 insp.
Barbara J Wilimczyk-Macri1 insp.
Jessica M Monteiro1 insp.
Maria Estrella1 insp.
Atul Agrawal1 insp.
Amy M Cramer1 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 | 4x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cosmax USA, Corporation's 6 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