FDA 483 - Craftmatic Industries, Inc. - February 12, 2020

Craftmatic Industries, Inc. in Pompano Beach, FL, a specification developer of adjustable therapeutic beds, received 13 observations during an FDA inspection. The firm failed to report a significant field correction for bed separation issues, inadequately handled and investigated numerous complaints, and demonstrated systemic deficiencies across its quality system, including CAPA, management review, purchasing controls, design controls, quality audits, and personnel training. These issues indicate a severe lack of adherence to regulatory requirements and internal procedures, posing potential risks to device users.