FDA Inspection 792740 — Hillestad Pharmaceuticals USA, Inc.
The FDA completed an inspection of Hillestad Pharmaceuticals USA, Inc. on May 27, 2012 in Woodruff, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 27, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Woodruff, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15550 | 21 CFR 111.260(j) | Batch record - manufacture |
| 15742 | 21 CFR 111.210(h)(3) | Specific actions; packaged, labeled |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15875 | 21 CFR 111.75(d)(1) | Documentation specifications met; exempted, periodic testing |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |