Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
2 Apr 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Crystal Monroy, Carolina D Vasquez
2 Apr 2026
21 CFR 211.194(a)(2)
Suitability of testing methods verified
Cited by Crystal Monroy, Carolina D Vasquez
2 Apr 2026
21 CFR 211.198(a)
Procedures to be written and followed
Cited by Crystal Monroy, Carolina D Vasquez
2 Apr 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Crystal Monroy, Carolina D Vasquez
2 Apr 2026
21 CFR 211.63
Equipment Design, Size and Location
Cited by Crystal Monroy, Carolina D Vasquez
Inspected site
SUSilgan Unicep Packaging, LLCSpokane, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 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