FDA Inspection
LifeLink Foundation, Inc.LifeLink Foundation, Inc. – FDA Inspection, May 11, 2018
Record Details
This FDA Inspection record concerns LifeLink Foundation, Inc., with an inspection on May 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8e9e71bf-808b-452d-867a-443103198bde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051751
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of LifeLink Foundation, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2026 | Not classified | Florida District Office | |
| July 15, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 30, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 12, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 24, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for LifeLink Foundation, Inc.
- FDA Inspection 1329424 - 2026-07-10
- FDA Inspection 1174553 - 2022-07-15
- FDA Inspection 1101762 - 2019-07-30
- FDA Inspection 1000165 - 2017-01-12
- FDA Inspection 917954 - 2015-02-24
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