FDA Inspection 823282 — Axium Healthcare Pharmacy dba Balanced Solutions Compounding
The FDA completed an inspection of Axium Healthcare Pharmacy dba Balanced Solutions Compounding on March 15, 2013 in Lake Mary, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 15, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Lake Mary, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |