FDA Inspection 716726 — H & P Industries, Inc.
The FDA completed an inspection of H & P Industries, Inc. on March 28, 2011 in Hartland, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 28, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hartland, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3555 | 21 CFR 211.48(b) | Drains--Size, Back-siphonage Prevention |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |