FDA Inspection 892555 — Hillestad Pharmaceuticals USA, Inc.
The FDA completed an inspection of Hillestad Pharmaceuticals USA, Inc. on August 20, 2014 in Woodruff, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 20, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Woodruff, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15875 | 21 CFR 111.75(d)(1) | Documentation specifications met; exempted, periodic testing |
| 15978 | 21 CFR 111.123(a)(2) | Quality control operations - batch production records |