Overview
- 7 public-safe observations are available for this inspection.
- 7 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.
27 May 2012
21 CFR 111.70(e)
Specifications - identity, purity, strength, composition
Cited by Justin A Boyd
27 May 2012
21 CFR 111.75(c)(3)
Specifications met identity,purity, strength, comp; basis
Cited by Justin A Boyd
27 May 2012
21 CFR 111.75(d)(1)
Documentation specifications met; exempted, periodic testing
Cited by Justin A Boyd
Inspected site
HPHillestad Pharmaceuticals USA, Inc.Woodruff, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.210(h)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 7 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