Overview
- 3 public-safe observations are available for this inspection.
- 3 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
7 Jan 2010
21 CFR 113.40(a)(1)(v)
TID not reference instrument
Cited by Brandon C Heitmeier, Clifton C Francis, Cheryl G Scott
7 Jan 2010
21 CFR 113.40(a)(8)
Bleeder size
Cited by Brandon C Heitmeier, Clifton C Francis, Cheryl G Scott
7 Jan 2010
21 CFR 113.100(a)
Process records - not done; not timely
Cited by Brandon C Heitmeier, Clifton C Francis, Cheryl G Scott
Inspected site
VAVietti Acquisitions, LLCNashville, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 113.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(a)(1)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 113.40(a)(8) | 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