FDA Inspection 973463 — Home Care Pharmacy of Palm Coast, Inc.
The FDA completed an inspection of Home Care Pharmacy of Palm Coast, Inc. on May 25, 2016 in Palm Coast, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 25, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Palm Coast, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4576 | 21 CFR 211.192 | No written record of investigation |