Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 5 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
20 Jan 2022
21 CFR 117.130(a)(1)
Hazard Analysis - Identification of Hazard
Cited by Jessica B Clark, Kaitlyn R Kornberg, Delanie M Browning, Patrick R Brown, Jessica B Zachman
20 Jan 2022
21 CFR 117.4
Qualifications of individuals
Cited by Jessica B Clark, Kaitlyn R Kornberg, Delanie M Browning, Patrick R Brown, Jessica B Zachman
20 Jan 2022
21 CFR 123.7(a)
Corrective action per predetermined plan
Cited by Jessica B Clark, Kaitlyn R Kornberg, Delanie M Browning, Patrick R Brown, Jessica B Zachman
Inspected site
PSPortland Sandwich Co.Portland, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 117.130(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 117.4 | 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 3 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