Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-16.
At a glance
Inspections
9
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Nov 2023 – 16 Feb 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Oct 2018 – 10 Oct 2018 | Medical Devices & Rad Health | Clean | |
| 29 Mar 2016 – 5 Apr 2016 | Medical Devices & Rad Health | 483 | On file |
| 8 Sep 2014 – 15 Sep 2014 | Medical Devices & Rad Health | Clean | |
| 25 Aug 2011 | Not recorded | Clean | |
| 31 Dec 2008 | Not recorded | Clean | |
| 30 Sep 2005 | Not recorded | Clean | |
| 27 Feb 2004 | Not recorded | Clean | |
| 7 Nov 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Feb 2024
21 CFR 820.25(b)
Training - Lack of or inadequate procedures
Cited by Eric C Schmitt, Diane M Biron
16 Feb 2024
21 CFR 820.70(e)
Contamination control, Lack of or inadequate procedures
Cited by Eric C Schmitt, Diane M Biron
16 Feb 2024
21 CFR 820.72(a)
Equipment control activity documentation
Cited by Eric C Schmitt, Diane M Biron
16 Feb 2024
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Eric C Schmitt, Diane M Biron
Investigators
FDA investigators tied to this site in the record.
Eric C Schmitt1 insp.
Diane M Biron1 insp.
Michael G Mayfield1 insp.
Maryam Tabatabaie1 insp.
Sandra P White1 insp.
Maura Rooney1 insp.
Lauren M Lawrance1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Professional Contract Sterilization, Inc.'s 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