Overview
- 14 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-21.
At a glance
Inspections
14
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 May 2024 – 21 May 2024 | Human Drugs | 483 | View 483 → |
| 2 May 2023 – 16 May 2023 | Medical Devices & Rad Health | Clean | |
| 7 Jul 2021 – 15 Jul 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Mar 2017 – 28 Mar 2017 | Human Drugs | 483 | View 483 → |
| 22 Mar 2016 – 31 Mar 2016 | Medical Devices & Rad Health | Clean | |
| 14 Nov 2014 – 17 Dec 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Aug 2014 – 20 Aug 2014 | Medical Devices & Rad Health | Clean | |
| 6 Mar 2014 – 10 Mar 2014 | Human Drugs | 483 | View 483 → |
| 16 Jan 2013 | Not recorded | 483 | View 483 → |
| 21 Mar 2011 | Not recorded | Clean | |
| 19 Jul 2009 | Not recorded | 483 | View 483 → |
| 21 Sep 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
21 May 2024
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Tanya R Syffrard, Pamela N Agaba, Tomika L Crafter
15 Jul 2021
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Stephen C Smith, Maura Rooney
15 Jul 2021
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by Stephen C Smith, Maura Rooney
15 Jul 2021
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Stephen C Smith, Maura Rooney
Investigators
FDA investigators tied to this site in the record.
Michael G Mayfield2 insp.
Maya M Davis2 insp.
Tanya R Syffrard1 insp.
Pamela N Agaba1 insp.
Tomika L Crafter1 insp.
Eric C Schmitt1 insp.
Stephen C Smith1 insp.
Maura Rooney1 insp.
Dien N Nguyen1 insp.
Jeffrey J Thibodeau1 insp.
Xiaojun Yan1 insp.
Janete F Guardia1 insp.
Mark R Mcclain1 insp.
Diane C Thibodeau1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.103 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.137(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CooperSurgical, Inc.'s 7 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