483
Join Parachute, LLCJoin Parachute, LLC – FDA 483, Jun 9, 2026
Record Details
Join Parachute, LLC, a Source Plasma facility in Crossville, TN, received two observations during an FDA inspection. The firm failed to submit a biological product deviation report (BPDR) within the required 45 days for a donor with a positive HCV NAT, submitting it significantly late. Additionally, the company did not consistently follow its own written standard operating procedures for biological product deviation reporting and the distribution of blood components for further manufacturing.
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ID · 8c46a585-21de-4532-8dae-edd405e66133
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