Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2021-09-16.
At a glance
Inspections
5
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Sep 2021 – 16 Sep 2021 | Medical Devices & Rad Health | Clean | |
| 24 Oct 2017 – 26 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 23 Jun 2015 – 25 Jun 2015 | Medical Devices & Rad Health | Clean | |
| 17 Oct 2012 | Not recorded | Clean | |
| 10 Jan 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Jan 2012
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Wilfred A Darang
Investigators
FDA investigators tied to this site in the record.
Wilfred A Darang5 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 821.25(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind H & H Medical's 1 Form 483
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