Overview
- 5 public-safe observations are available for this inspection.
- 5 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 Jul 2014
21 CFR 211.67(c)
Cleaning/maintenance records not kept
Cited by Michele Perry-Williams, Michele Perry Williams
2 Jul 2014
21 CFR 226.40(e)
Cleaning to prevent contamination of Type A articles
Cited by Michele Perry-Williams, Michele Perry Williams
2 Jul 2014
21 CFR 226.80(b)(2)
Label examination
Cited by Michele Perry-Williams, Michele Perry Williams
2 Jul 2014
21 CFR 226.115
Appropriate action not taken
Cited by Michele Perry-Williams, Michele Perry Williams
Inspected site
HIHuvepharma, Inc.Saint Louis, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 226.110 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 226.115 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 226.40(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 226.80(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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