FDA Inspection 1263852 — PALMETTO ISOTOPES, LLC
The FDA completed an inspection of PALMETTO ISOTOPES, LLC on February 28, 2025 in Ridgeland, SC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 28, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ridgeland, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18943 | FDCA 501(a)(2)(A) | Personnel in aseptic processing, non-sterile gloves |
| 22749 | FDCA 501(a)(2)(A) | Production areas, difficult to clean/particle generating |
| 22759 | FDCA 501(a)(2)(A) | Sporicidal agent, ISO 5/classified areas |
| 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 |