FDA 483 - Forbes Rehab Services Inc - October 27, 2021

Forbes Rehab Services Inc, a medical device manufacturer in Mansfield, OH, was cited for numerous quality system deficiencies during an FDA inspection. The observations highlight inadequate procedures across critical areas such as purchasing, corrective and preventive actions, internal audits, complaint handling, training, process validation, design change, equipment maintenance, and control of nonconforming product. These issues indicate a systemic failure to establish and adhere to robust quality management practices.