483
Radienz Living LLCRadienz Living LLC – FDA 483, Jan 11, 2024
Record Details
Radienz Living LLC in Commack, NY, was cited with six observations during an FDA inspection concerning its manufacturing of Hemorrhoidal Pads. The firm failed to validate manufacturing processes and cleaning procedures, and lacked proper controls over computerized laboratory systems, allowing data alteration. Additionally, equipment was not qualified, storage conditions were unmonitored, and batch records were incomplete.
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ID · 4908cf82-4e17-4ab4-a625-ed021d6ba217
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