FDA Inspection
Bedford Research Foundation, Inc.Bedford Research Foundation, Inc. – FDA Inspection, Sep 11, 2017
Record Details
This FDA Inspection record concerns Bedford Research Foundation, Inc., with an inspection on September 11, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Person
- Alice C. Silva (Issuing Officer)
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ID · 9a3fb2bd-cc48-4b63-9461-3f5c4504d505
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025486
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
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Other FDA inspections of Bedford Research Foundation, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 15, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 14, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 15, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 18, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Bedford Research Foundation, Inc.
- FDA Inspection 1297208 - 2025-12-11
- FDA Inspection 1216522 - 2023-08-15
- FDA Inspection 1065596 - 2018-09-14
- FDA Inspection 878835 - 2014-05-15
- FDA Inspection 750730 - 2011-10-18
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