Rpk Pharmaceuticals IncOctober 14, 2021

FDA 483 - Rpk Pharmaceuticals Inc - October 14, 2021

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Record Details

An FDA inspection of RPK Pharmaceuticals Inc, a drug repackaging/relabeling facility in Union City, CA, revealed significant deficiencies. The firm failed to follow written procedures for handling expired products and maintaining reserved samples. Additionally, cleaning and maintenance procedures for equipment were found to be deficient, with expired cleaning supplies observed in use.

Company: Rpk Pharmaceuticals Inc
Inspection Date: October 14, 2021
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West V
People: Matthew R. Clabeaux
Gunneet Kaur (Stryker, Regulatory Affairs)

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ID · ee539f9e-8088-44ee-9bc1-4548c62fb828