FDA Inspection 1210975 — Pelex Medical Of Texas
The FDA completed an inspection of Pelex Medical Of Texas on Jul 28, 2023 in Lubbock, 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
- Jul 28, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Lubbock, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |