Overview
- 10 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-24.
At a glance
Inspections
10
Form 483s
6
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Mar 2026 – 24 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Jan 2024 – 1 Feb 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Feb 2022 – 4 Mar 2022 | Human Drugs | 483 | View 483 → |
| 29 Jul 2019 – 1 Aug 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Mar 2014 – 21 Mar 2014 | Human Drugs | 483 | On file |
| 25 Jun 2013 – 28 Jun 2013 | Human Drugs | Clean | |
| 23 May 2012 | Not recorded | 483 | View 483 → |
| 15 Sep 2009 | Not recorded | Clean | |
| 26 May 2009 | Not recorded | Clean | |
| 29 Oct 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Mar 2026
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Matthew D Schnittker, Karen A Briggs, Jordan S Burkdoll
24 Mar 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Matthew D Schnittker, Karen A Briggs, Jordan S Burkdoll
24 Mar 2026
21 CFR 211.170(b)
Annual visual exams of drug products
Cited by Matthew D Schnittker, Karen A Briggs, Jordan S Burkdoll
24 Mar 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Matthew D Schnittker, Karen A Briggs, Jordan S Burkdoll
24 Mar 2026
21 CFR 211.198(b)(2)
Written record of complaint to include findings, follow-up
Cited by Matthew D Schnittker, Karen A Briggs, Jordan S Burkdoll
Investigators
FDA investigators tied to this site in the record.
Matthew D Schnittker3 insp.
James D Bridges2 insp.
Karen L Kosar2 insp.
Karen A Briggs1 insp.
Jordan S Burkdoll1 insp.
Sony Mathews1 insp.
Brandy N Lepage1 insp.
Syeda N Mahazabin1 insp.
Nancy M Espinal1 insp.
David A Carlson1 insp.
Joanne M Schlossin1 insp.
Joseph J Vannelli1 insp.
Thomas P Hansen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CooperSurgical, Inc.'s 6 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