FDA Inspection 640282 — Clinical Pathology Laboratories
The FDA completed an inspection of Clinical Pathology Laboratories on January 22, 2010 in Austin, 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 22, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Austin, 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 |
| 12279 | 21 CFR 1271.75(b) | Risk factors, leukocyte-rich cells or tissues |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12490 | 21 CFR 1271.85(b)(1) | Cell-associated CD |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |