FDA Inspection
Westchester Medical Center Pathology DepartmentWestchester Medical Center Pathology Department – FDA Inspection, Jun 20, 2011
Record Details
This FDA Inspection record concerns Westchester Medical Center Pathology Department, with an inspection on June 20, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 20, 2011
- Product Type
- Biologics
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ID · fccc5341-a082-4b2c-8672-a824f37df430
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 728334
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.210(d)(2)Verification elements
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.230(a)Process validation procedures
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.270(a)Records incomplete
- 21 CFR 1271.210(a)Use prior to verification
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Other FDA inspections of Westchester Medical Center Pathology Department
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2024 | Not classified | New York District Office | |
| July 8, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 23, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Westchester Medical Center Pathology Department
- FDA Inspection 1255924 - 2024-11-20
- FDA Inspection 1175324 - 2022-07-08
- FDA Inspection 1086871 - 2019-01-23
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