The FDA hit Pukang Medical on its design control and quality processes. The agency issued a Form 483 following a January inspection of the electric hospital bed manufacturer’s Hebei, China, facility.
The company’s Class II AC-powered adjustable hospital beds did not go through the design control process, and the firm has yet to establish design control procedures, according to the 483.The firm has been shipping the AC-Powered Adjustable Hospital Beds to the U.S. for 10 years.
The agency also cited the firm for lack of CAPA procedures or device history records, with investigators finding several cases of beds manufactured for the U.S. market with no DHRS to indicate compliance with the device master records. Other deficiencies included damaged pumps on wheeled stretchers, an infant hospital bed with the wrong frame and rust on a hydraulic bed. The firm also conducted no quality audits to ensure its quality system is compliant and effective.