FDA Inspection 1281314 — Donor Services Laboratories Inc Tampa
The FDA completed an inspection of Donor Services Laboratories Inc Tampa on September 12, 2025 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 12, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |