FDA Inspection 727085 — Hillestad Pharmaceuticals USA, Inc.
The FDA completed an inspection of Hillestad Pharmaceuticals USA, Inc. on May 12, 2011 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). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 12, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Woodruff, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |