Overview
- 9 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
1 Dec 2022
21 CFR 108.35(c)(3)(i)
Process adherence
Cited by Celia L Hutchinstein, Devon M Shoop, James E Trabert
1 Dec 2022
21 CFR 108.35(c)(3)(i)
Process adherence
Cited by Celia L Hutchinstein, Devon M Shoop, James E Trabert
1 Dec 2022
21 CFR 108.35(c)(3)(i)
Process adherence
Cited by Celia L Hutchinstein, Devon M Shoop, James E Trabert
1 Dec 2022
21 CFR 113.40(j)
Critical factors - frequency measured, recorded
Cited by Celia L Hutchinstein, Devon M Shoop, James E Trabert
1 Dec 2022
21 CFR 113.40(j)
Critical factors - frequency measured, recorded
Cited by Celia L Hutchinstein, Devon M Shoop, James E Trabert
Inspected site
SCSeabear CompanyAnacortes, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 108.35(c)(3)(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 113.40(j) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 123.11(b) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 9 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