483
KEDPLASMA LLCKEDPLASMA LLC – FDA 483, Apr 16, 2026
Record Details
An FDA inspection of KEDPLASMA LLC in Cinnaminson, NJ, revealed a significant failure in reporting. The firm did not submit a Biological Product Deviation report after allowing a donor with an unacceptable address to make continuous source plasma donations, and subsequently distributing these units. This indicates a lapse in compliance with regulatory reporting requirements for biological products.
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ID · 02acc038-0fce-40fc-bfa7-e2eaa100de0c
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