1259930
Carolina Infusion — FEI 3015826782
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 24, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ridgeland, SC (United States)
Citations
| ID | CFR | Description |
|---|
| 22733 | FDCA 501(a)(2)(A) | Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination |
| 22742 | FDCA 501(a)(2)(A) | Exposed to lower quality air/ISO 5 |
| 22761 | FDCA 501(a)(2)(A) | Lack of disinfection, equipment/supplies from lower to higher quality air |
| 22763 | FDCA 501(a)(2)(A) | Lack of/inadequate, environmental monitoring |
| 22766 | FDCA 501(a)(2)(A) | Inadequate smoke studies |
| 22769 | FDCA 501(a)(2)(A) | Media fills, failure |