Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-05-14.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 May 2019 – 14 May 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Feb 2017 – 14 Feb 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Mar 2014 – 7 Mar 2014 | Medical Devices & Rad Health | Clean | |
| 25 Apr 2011 | Not recorded | 483 | View 483 → |
| 26 Sep 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
14 May 2019
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Jesse A Vazquez, Natasha R Johnson
14 May 2019
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Jesse A Vazquez, Natasha R Johnson
Investigators
FDA investigators tied to this site in the record.
Jesse A Vazquez1 insp.
Natasha R Johnson1 insp.
Amanda Dinaro1 insp.
Paola S Barnett1 insp.
Rafael Padilla1 insp.
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 | 4x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | 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 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.186 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | 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 Hospital Therapy Products Inc.'s 3 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