Overview
- 10 public-safe observations are available for this inspection.
- 10 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
28 Jun 2011
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Justine M Corson, Camerson E Moore, Elizabeth B Griffin, Charles R Clavet
28 Jun 2011
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Justine M Corson, Camerson E Moore, Elizabeth B Griffin, Charles R Clavet
28 Jun 2011
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Justine M Corson, Camerson E Moore, Elizabeth B Griffin, Charles R Clavet
28 Jun 2011
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Justine M Corson, Camerson E Moore, Elizabeth B Griffin, Charles R Clavet
28 Jun 2011
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Justine M Corson, Camerson E Moore, Elizabeth B Griffin, Charles R Clavet
Inspected site
VLVerichem Laboratories, Inc.Providence, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.140 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 10 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