Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-24.
At a glance
Inspections
7
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2025 – 24 Jul 2025 | Human Drugs | 483 | View 483 → |
| 15 Jul 2022 – 25 Jul 2022 | Human Drugs | Clean | |
| 15 Sep 2016 – 21 Sep 2016 | Medical Devices & Rad Health | Clean | |
| 26 Aug 2013 – 11 Sep 2013 | Human Drugs | 483 | On file |
| 14 Oct 2009 | Not recorded | 483 | On file |
| 15 Sep 2005 | Not recorded | Clean | |
| 11 Feb 2005 | 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.
Deborah A Greco1 insp.
Shirley S Wen1 insp.
Loretta Nemchik1 insp.
Denise M Visco1 insp.
Dawn L Wydner1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.41 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Product Safety Labs' 3 Form 483s
Source PDFs 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