FDA Inspection 697221 — H & P Industries, Inc.
The FDA completed an inspection of H & P Industries, Inc. on November 10, 2010 in Hartland, WI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 18 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 10, 2010
- Fiscal Year
- 2011
- 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 |
| 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 |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1958 | 21 CFR 211.180(f) | Responsible firm officials notified in writing |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |