483
Join Parachute 2 LLCFDA 483 - Join Parachute 2 LLC
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Record Details
An FDA inspection of Join Parachute, LLC's plasmapheresis center in Bay City, TX, revealed significant deficiencies. Observations included inadequate space and privacy for donor screening, insufficient ventilation, and critical failures in quarantining and destroying units from reactive donors. The firm also failed to properly defer a donor after an unacceptable NDDR check, indicating systemic issues in donor management and quality control.
- Company
- Join Parachute 2 LLC
- Product Type
- Biologics
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ID · 3f95e1a9-1e1c-4bce-81b9-669639b78e73