Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
5 Mar 2018
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by La-Tasha M Gunter
5 Mar 2018
21 CFR 606.40(a)(6)
Provide space for quarantine of unsuitable for use items
Cited by La-Tasha M Gunter
Inspected site
DODepartment of Veterans Affairs Medical CenterWashington, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.40(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.65 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 3 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