Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-09-11.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Sep 2015 – 11 Sep 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Sep 2012 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Sep 2015
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by James M Odonnell
11 Sep 2015
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by James M Odonnell
Investigators
FDA investigators tied to this site in the record.
James M Odonnell1 insp.
Elizabeth D Connell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Coopervision Manaufacturing, Ltd.'s 2 Form 483s
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