Overview
- 6 public-safe observations are available for this inspection.
- 6 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
WIWHPM Inc.Irwindale, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(2) | 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 |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 6 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere