A Kansas manufacturer of bariatric hospital beds, air mattresses, wheelchairs and scooters was 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 and suggestions were not dated consistently, and were not evaluated to determine if an investigation was needed.
The company also failed to establish assembly procedures for several of its products. In addition, the facility’s supplier records were incomplete.