A California photographic equipment company failed to file a required report with the FDA about a modification made to a camera to reduce a health risk in response to a customer complaint, the agency said in a Form 483 report.
The company, Motion Analysis, of Santa Rosa, also lacked adequate procedures for reporting such incidents and for receiving and investigating complaints, the FDA said in the report on its July inspection. Several of the findings had been noted in a 2016 inspection, the report said.
Motion Analysis manufactures cameras and other equipment to capture and measure the movement of humans and objects. The company sells its products for use in sports and physical training, film and video production, industrial design and other areas.