FDA Inspection 1250451 — E2P4 Labs
The FDA completed an inspection of E2P4 Labs on Sep 17, 2024 in Plano, TX. 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
- Sep 17, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |