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.
7 Mar 2016
21 CFR 606.100(b)(16)
Labeling procedures to avoid labeling mix-ups
Cited by Anthony N Onianwa
7 Mar 2016
21 CFR 606.121(c)(13)
Unapproved encoded/machine readable information
Cited by Anthony N Onianwa
Inspected site
VHVACT Healthcare SystemWest Haven, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b)(16) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.121(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.121(c)(13) | 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