FDA Inspection 728334 — Westchester Medical Center Pathology Department
The FDA completed an inspection of Westchester Medical Center Pathology Department on Jun 20, 2011 in Valhalla, NY. 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 20, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Valhalla, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12381 | 21 CFR 1271.210(d)(2) | Verification elements |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |