483
Empire Medical Practice, PC d.b.a KindbodyEmpire Medical Practice, PC d.b.a Kindbody – FDA 483, Sep 3, 2021
Record Details
An FDA inspection of Empire Medical Practice, PC d.b.a Kindbody in New York, NY, a reproductive human tissue establishment, revealed one significant observation. The firm failed to ensure HCT/P donors were determined eligible based on complete donor screening and testing results. Specifically, a donor was deemed eligible before all communicable disease test results were available.
- Inspection date
- September 3, 2021
- Product type
- biologics
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ID · 6eb466cf-6586-4831-bfd0-36e3dba6b0fb
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