Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-05.
At a glance
Inspections
8
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Mar 2025 – 5 Mar 2025 | Human Drugs | Clean | |
| 4 Nov 2019 – 5 Nov 2019 | Human Drugs | Clean | |
| 25 Sep 2018 – 27 Sep 2018 | Human Drugs | WL | On file |
| 11 Oct 2017 – 12 Oct 2017 | Human Drugs | 483 | View 483 → |
| 8 Jul 2015 – 15 Jul 2015 | Human Drugs | Clean | |
| 18 Apr 2013 | Human Drugs | 483 | On file |
| 10 Mar 2005 | Not recorded | Clean | |
| 16 Jun 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Darren S Brown1 insp.
Anita Narula1 insp.
Rumany C Penn1 insp.
Tamara L Ely1 insp.
Yasamin Ameri1 insp.
Sundy Ven1 insp.
Thao T Kwan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Asclemed USA Inc. dba Enovachem's 3 Form 483s
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