Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-01-27.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Jan 2016 – 27 Jan 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Dec 2013 – 23 Dec 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Oct 2011 | Not recorded | 483 | View 483 → |
| 11 May 2010 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jan 2016
21 CFR 820.30(e)
Design review - Lack of or inadequate procedures
Cited by Deanna L Lampley
27 Jan 2016
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Deanna L Lampley
27 Jan 2016
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Deanna L Lampley
27 Jan 2016
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Deanna L Lampley
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Peninsula Medical Products, LLC's 4 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