FDA Inspection 597616 — H & P Industries, Inc.
The FDA completed an inspection of H & P Industries, Inc. on July 17, 2009 in Hartland, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 21 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 17, 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 |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1456 | 21 CFR 211.115(b) | Reprocessing/quality control unit |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |