FDA Inspection
AlloSourceAlloSource – FDA Inspection, Oct 3, 2008
Record Details
This FDA Inspection record concerns AlloSource, with an inspection on October 3, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- AlloSource
- Inspection Date
- October 3, 2008
- Product Type
- Biologics
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ID · 1ccd910f-695b-421b-a0f6-a9be6635faca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 544221
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.230(c)Changes to validated process
- 21 CFR 1271.195(d)Documentation not maintained
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.180(c)Availability of procedures
- 21 CFR 1271.200(c)Calibration procedures and schedules (general)
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Other FDA inspections of AlloSource
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 26, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for AlloSource
- FDA Inspection 1278944 - 2025-08-04
- FDA Inspection 1083311 - 2019-02-26
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