Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Sep 2019
21 CFR 117.145(a)
Sanitation Controls Monitoring Proced: Establish Implement
Cited by Andrea J Schmidt, Gina M Scholze, Jamie L Port, Oluwaseyi Ojinni
5 Sep 2019
21 CFR 117.20(b)
Plant Construction and Design
Cited by Andrea J Schmidt, Gina M Scholze, Jamie L Port, Oluwaseyi Ojinni
5 Sep 2019
21 CFR 117.80(c)(8)
Process Control - Foreign Objects
Cited by Andrea J Schmidt, Gina M Scholze, Jamie L Port, Oluwaseyi Ojinni
Inspected site
DHDPB Holding, inc.Brighton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.145(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.80(c)(8) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 observations
Every observation in full, 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