FDA Inspection 1115094 — Scott & White Medical Center- Temple Andrology Laboratory
The FDA completed an inspection of Scott & White Medical Center- Temple Andrology Laboratory on January 8, 2020 in Temple, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 8, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Temple, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12489 | 21 CFR 1271.90(c)(1) | Autologous use only--labeling |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |