Overview
- 14 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-06-04.
At a glance
Inspections
14
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 May 2025 – 4 Jun 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Apr 2024 – 8 May 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 30 Aug 2021 – 14 Sep 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jan 2020 – 7 Feb 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 May 2018 – 14 Jun 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jan 2017 – 26 Jan 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Feb 2015 – 13 Mar 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Jun 2014 – 16 Jul 2014 | Medical Devices & Rad Health | 483 | On file |
| 31 Jul 2013 – 2 Aug 2013 | Medical Devices & Rad Health | Clean | |
| 26 Jul 2012 | Not recorded | 483 | View 483 → |
| 5 Oct 2010 | Not recorded | Clean | |
| 12 Dec 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Jun 2025
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Suyang Qin, Felicia E Armbrustmacher
4 Jun 2025
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Suyang Qin, Felicia E Armbrustmacher
4 Jun 2025
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Suyang Qin, Felicia E Armbrustmacher
4 Jun 2025
21 CFR 820.70(g)
Equipment Installation, Placement, Specified Requirements
Cited by Suyang Qin, Felicia E Armbrustmacher
Investigators
FDA investigators tied to this site in the record.
Joseph R Strelnik4 insp.
Debara R Reese3 insp.
Suyang Qin1 insp.
Felicia E Armbrustmacher1 insp.
Shannon A Gregory1 insp.
Talmane J Fisher1 insp.
Sargum C Sood1 insp.
Sean T Creighton1 insp.
Andrea D Swingle1 insp.
Patrick B Cummings1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cook Incorporated's 9 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