FDA EIR - Assemblers Inc. - October 17, 2013

Assemblers, Inc., a contract manufacturer of various food products, underwent a surveillance inspection by the FDA on July 25, 2017. Conducted under Compliance Program 7303.803 for Domestic Food Safety, the inspection evaluated the firm's adherence to cGMPs, sanitation, quality control, and other operational procedures. While no formal FDA Form 483 was issued, several observations were discussed with management. Noted issues included insufficient spacing for warehouse stacks, presence of dust and debris in some warehouse areas, and the absence of toilet paper and hand towels in a men's washroom. Additionally, dense grease stains were observed around the compactor, a red-tagged Quality Control HOLD item was found incorrectly stored in an allergen-dedicated area, and an employee needed to re-sanitize hands upon re-entry to the production area. Management committed to promptly addressing and correcting all identified observations, demonstrating their intent to maintain regulatory compliance and high operational standards.