FDA Inspection 1211023 — New Vitalis Pharmacy LLC
The FDA completed an inspection of New Vitalis Pharmacy LLC on July 5, 2023 in Louisville, KY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 5, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22738 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical, ingredients/processing aides |
| 22740 | FDCA 501(a)(2)(A) | Personnel infrequently, changed/sanitized gloves |
| 22744 | FDCA 501(a)(2)(A) | Personnel, blocked or disrupted first air |
| 22751 | FDCA 501(a)(2)(A) | Facility design, influx of lesser quality air |
| 22753 | FDCA 501(a)(2)(A) | HEPA filters, not sealed |
| 22758 | FDCA 501(a)(2)(A) | Non-sterile disinfecting agents, ISO 5 area/classified areas |
| 22759 | FDCA 501(a)(2)(A) | Sporicidal agent, ISO 5/classified areas |
| 22762 | FDCA 501(a)(2)(A) | Insufficient use, disinfectant |
| 22766 | FDCA 501(a)(2)(A) | Inadequate smoke studies |
| 22769 | FDCA 501(a)(2)(A) | Media fills, failure |
| 22770 | FDCA 501(a)(2)(A) | Failure/inadequate, filter integrity testing |