Overview
- 9 public-safe observations are available for this inspection.
- 3 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 May 2017
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by John A Sciacchitano, Brian R Sweeney
2 May 2017
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by John A Sciacchitano, Brian R Sweeney
2 May 2017
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by John A Sciacchitano, Brian R Sweeney
Inspected site
OIOmniGuide, Inc.Billerica, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1002.13 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 3x |
Full 483 report
Get the verbatim text of all 9 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