Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
7 Nov 2023
21 CFR 117.206(a)
Modified requirement: Temperature control - Implement
Cited by Erica B Raphael, Erica B Brush
7 Nov 2023
21 CFR 123.7(a)
Corrective action per predetermined plan
Cited by Erica B Raphael, Erica B Brush
Inspected site
8N8617 Northern Blvd CorpWoodside, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.206(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.12(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.6(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 123.7(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 observations
The full inspection record, as Atlas holds it, 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