FDA Inspection
Clinical Pathology LaboratoriesClinical Pathology Laboratories – FDA Inspection, Jan 22, 2010
Record Details
This FDA Inspection record concerns Clinical Pathology Laboratories, with an inspection on January 22, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- January 22, 2010
- Product Type
- Biologics
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ID · ee76e5df-d6be-44fb-ab45-2e781dc7e0ab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 640282
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
8- 21 CFR 1271.85(b)(2)SOP for release; reactive for CMV
- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.75(b)Risk factors, leukocyte-rich cells or tissues
- 21 CFR 1271.85(b)(1)Cell-associated CD
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.50(a)Responsible person to determine, document
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Other FDA inspections of Clinical Pathology Laboratories
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 14, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 5, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 6, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 25, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Clinical Pathology Laboratories
- FDA Inspection 1116378 - 2020-01-14
- FDA Inspection 1040462 - 2018-01-05
- FDA Inspection 902884 - 2014-11-06
- FDA Inspection 791867 - 2012-07-25
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