FDA Inspection 841366 — Beacon Hill Medical Pharmacy, P.C.
The FDA completed an inspection of Beacon Hill Medical Pharmacy, P.C. on July 19, 2013 in Southfield, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 19, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Southfield, MI (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 |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |