FDA Inspection 1249766 — Eurofins CellTx Inc
The FDA completed an inspection of Eurofins CellTx Inc on Sep 20, 2024 in Tucson, AZ. 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 20, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12368 | 21 CFR 1271.200(a) | Capable of valid results |
| 12377 | 21 CFR 1271.210(c) | In-house reagent production |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |