Acorn Stairlifts drew a Form 483 from the FDA for inadequate CAPA procedures and other issues at its facility in Orlando, Fla.

In a December 2016 inspection, the investigator observed a lack of follow-up to complaints – including one reported to the FDA as a serious injury – regarding the weight capacity of seats; and procedures that did not require all CAPAs to be validated as effective.

The FDA also said the company lacked approved procedures to ensure proper evaluation of supplier operations, including welding and molding, training, and environmental controls.