FDA Inspection 1235906 — Donor Services Laboratory, Inc. Las Vegas
The FDA completed an inspection of Donor Services Laboratory, Inc. Las Vegas on Apr 12, 2024 in Las Vegas, NV. 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 12, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Las Vegas, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12368 | 21 CFR 1271.200(a) | Capable of valid results |
| 12382 | 21 CFR 1271.210(d)(3) | Lot documentation maintained |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 15019 | 21 CFR 1271.160(d) | Computer software verification |