FDA Inspection
Lake Superior Centre For Regenerative MedicineLake Superior Centre For Regenerative Medicine – FDA Inspection, Sep 12, 2025
Record Details
This FDA Inspection record concerns Lake Superior Centre For Regenerative Medicine, with an inspection on September 12, 2025, issued by the Office of Inspections and Investigations, covering biologics.
- Inspection Date
- September 12, 2025
- Product Type
- Biologics
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ID · 8d0c43b1-9699-4fa5-ad59-b239da9a31f2
Inspection Facts
- Inspection number
- 1281308
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.180(a)Design adequate to bar spread of CD's
- 21 CFR 1271.190(b)(1)Clean, sanitary, orderly manner
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.220(a)Causing contamination, increasing risks
- 21 CFR 1271.230(a)Validation & approval--established procedures
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