Overview
- 8 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-30.
At a glance
Inspections
8
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Jan 2024 – 30 Jan 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Nov 2022 – 18 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Feb 2022 – 28 Feb 2022 | Medical Devices & Rad Health | 483 | On file |
| 12 Nov 2014 – 13 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 31 Oct 2012 | Not recorded | Clean | |
| 1 Jul 2010 | Not recorded | 483 | On file |
| 19 Dec 2008 | Not recorded | 483 | View 483 → |
| 12 Nov 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Jan 2024
21 CFR 820.184
DHR - not or inadequately maintained
Cited by Marlo-Ian M Alintanahin, Linda Galindo
30 Jan 2024
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Marlo-Ian M Alintanahin, Linda Galindo
30 Jan 2024
21 CFR 820.70(g)(2)
Periodic equipment inspections
Cited by Marlo-Ian M Alintanahin, Linda Galindo
30 Jan 2024
21 CFR 820.90(a)
Nonconforming product control
Cited by Marlo-Ian M Alintanahin, Linda Galindo
Investigators
FDA investigators tied to this site in the record.
Sonya L Karsik6 insp.
Marlo-Ian M Alintanahin2 insp.
Brian P Putz2 insp.
Linda Galindo1 insp.
Creighton T Tuzon1 insp.
Terri E Gibson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120 | 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 820.22 | 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(b) | 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 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.60 | 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(g)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(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(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | 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 WHPM Inc.'s 6 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