Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-05-21.
At a glance
Inspections
4
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 May 2021 – 21 May 2021 | Medical Devices & Rad Health | Clean | |
| 19 Mar 2018 – 13 Apr 2018 | Medical Devices & Rad Health | WL | View 483 → |
| 5 Feb 2014 – 12 Feb 2014 | Medical Devices & Rad Health | Clean | |
| 4 May 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Apr 2018
21 CFR 58.105(d)
Test article: reserve sample retention
Cited by Nicole C Victoria, Kellie L Thommes
13 Apr 2018
21 CFR 58.31(f)
Management: personnel understand their functions
Cited by Nicole C Victoria, Kellie L Thommes
13 Apr 2018
21 CFR 58.33(e)
Study director: follow GLP regulations
Cited by Nicole C Victoria, Kellie L Thommes
Investigators
FDA investigators tied to this site in the record.
Nicole C Victoria2 insp.
Sharon L Matson2 insp.
Hugh M Mcclure1 insp.
Kellie L Thommes1 insp.
Denise L Burosh1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.105(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind American Preclinical Services' 2 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