FDA Inspection 1149996 — New Vitalis Pharmacy LLC
The FDA completed an inspection of New Vitalis Pharmacy LLC on August 27, 2021 in Louisville, KY. 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
- August 27, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18934 | FDCA 501(a)(2)(A) | Vermin, adjacent area |
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production 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 |
| 18949 | FDCA 501(a)(2)(A) | First pass air blockage, open unit with sterile product |
| 18964 | FDCA 501(a)(2)(A) | Unsealed HEPA filter, perimeter |