FDA Inspection 919303 — Health Innovations Pharmacy, Inc
The FDA completed an inspection of Health Innovations Pharmacy, Inc on February 27, 2015 in Southern Pines, NC. 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
- February 27, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Southern Pines, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |