Radienz Living LLCJanuary 11, 2024

FDA 483 - Radienz Living LLC - January 11, 2024

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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.

Company: Radienz Living LLC
Inspection Date: January 11, 2024
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
People: Syeda N. Mahazabin (Drug Investigator)
Victoria Spivak (Pharmacist | Consumer Safety Officer)

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ID · 4908cf82-4e17-4ab4-a625-ed021d6ba217