FDA Inspection
AlloSourceAlloSource – FDA Inspection, Aug 28, 2026
Record Details
This FDA Inspection record concerns AlloSource, with an inspection on August 28, 2026, issued by the Denver District Office, covering biologics.
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ID · 2a5be685-c931-464a-b381-88ded2053088
Inspection Facts
- Inspection number
- 1333098
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
- 21 CFR 1271.190(b)(1)Clean, sanitary, orderly manner
- 21 CFR 1271.265(c)(2)Improperly released for distribution
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
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Other FDA inspections of AlloSource
8| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| July 27, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 9, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for AlloSource
- FDA Inspection 1201259 - 2023-03-30
- FDA Inspection 1175639 - 2022-07-27
- FDA Inspection 1074854 - 2018-12-18
- FDA Inspection 1010063 - 2017-02-09
- FDA Inspection 929703 - 2015-06-11
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