FDA Inspection 1099150 — Medoz Pharmacy Of Polk Inc
The FDA completed an inspection of Medoz Pharmacy Of Polk Inc on Aug 9, 2019 in Davenport, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 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 |