FDA Inspection 644521 — Hill Dermaceuticals, Inc.
The FDA completed an inspection of Hill Dermaceuticals, Inc. on February 19, 2010 in Sanford, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 19 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 19, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1509 | 21 CFR 211.122(h) | Printing devices |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2017 | 21 CFR 211.188(b)(5) | In-Process and Laboratory Control Results |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2035 | 21 CFR 211.194(e) | Stability testing records not included |
| 2397 | 21 CFR 211.194(a)(1) | Description and Identification of Samples |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3615 | 21 CFR 211.160(b)(4) | Test devices not meeting specifications |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4345 | 21 CFR 211.160(b)(1) | Samples (various types) representative, identified properly |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |