Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
23 Jan 2014
21 CFR 820.22
Quality audits - auditor independence
Cited by James D Hildreth, Gloria J Baca
23 Jan 2014
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by James D Hildreth, Gloria J Baca
23 Jan 2014
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by James D Hildreth, Gloria J Baca
23 Jan 2014
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by James D Hildreth, Gloria J Baca
23 Jan 2014
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by James D Hildreth, Gloria J Baca
Inspected site
SMSonivate Medical, Inc.Portland, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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