FDA Inspection 557911 — H & P Industries, Inc.
The FDA completed an inspection of H & P Industries, Inc. on February 5, 2009 in Hartland, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 5, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hartland, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |