Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
16 Jun 2011
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Shafiq Ahadi, Sherry G Bous, Adree N Anderson
16 Jun 2011
21 CFR 211.42(c)(2)
Rejected Material Area
Cited by Shafiq Ahadi, Sherry G Bous, Adree N Anderson
16 Jun 2011
21 CFR 211.42(c)(7)
Quarantined Drug Products Area
Cited by Shafiq Ahadi, Sherry G Bous, Adree N Anderson
16 Jun 2011
21 CFR 211.67(b)
Written procedures fail to include
Cited by Shafiq Ahadi, Sherry G Bous, Adree N Anderson
16 Jun 2011
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Shafiq Ahadi, Sherry G Bous, Adree N Anderson
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 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(7) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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