1099150
Medoz Pharmacy of Polk Inc — FEI 3015316526
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 9, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Davenport, FL (United States)
Citations
| ID | CFR | Description |
| 18933 | FDCA 501(a)(2)(A) | Vermin, production area |
| 18934 | FDCA 501(a)(2)(A) | Vermin, adjacent area |
| 18938 | FDCA 501(a)(2)(A) | Hazardous drugs, prevention of cross-contamination |
| 18941 | FDCA 501(a)(2)(A) | Improper gowning, contamination |
| 18942 | FDCA 501(a)(2)(A) | Personnel habits, contamination |
| 18950 | FDCA 501(a)(2)(A) | Personnel contact on container or closure |
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18964 | FDCA 501(a)(2)(A) | Unsealed HEPA filter, perimeter |
| 18971 | FDCA 501(a)(2)(A) | No sporicidal agents, cleanroom and ISO 5 area |