FDA Inspection 934241 — Hartley Medical Center Pharmacy, Incorporated
The FDA completed an inspection of Hartley Medical Center Pharmacy, Incorporated on July 8, 2015 in Long Beach, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 8, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Long Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |