FDA 483 - Pacon Manufacturing Corporation - March 13, 2020

During an inspection, Pacon Manufacturing Corporation, a manufacturer of surgical drapes in Somerset, NJ, was cited for failing to establish adequate procedures to prevent contamination. The firm's production areas for surgical drapes showed issues with foreign matter, including improper staging of raw materials, insufficient floor cleaning, and uncontrolled storage of in-process products, indicating a risk to product quality.