FDA Inspection 1237566 — Eclipse Technology Solutions Inc
The FDA completed an inspection of Eclipse Technology Solutions Inc on May 1, 2024 in Chadds Ford, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 1, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chadds Ford, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |