Bariatric Equipment Manufacturer Mishandling Complaints, FDA Says
A Kansas manufacturer of bariatric hospital beds, air mattresses, wheelchairs and scooters has been cited by the FDA for documentation and procedural lapses.
The company, Burke Inc., mishandled customer complaints and suggestions, the agency said. The reports of complaints were not dated consistently, and were not evaluated to determine if an investigation was merited, the agency said.
The company also failed to establish procedures for the assembly of several of its products, and its supplier records were incomplete, the agency said.