Anacom General Corporation – FDA 483, Jul 12, 2019

Anacom General Corporation DBA Anacom MedTek, a medical device manufacturer in Anaheim, CA, was cited with nine observations during an FDA inspection. The inspection revealed significant deficiencies across multiple quality system areas, including a lack of established procedures for finished device acceptance, incoming product acceptance, corrective and preventive actions, supplier control, complaint handling, nonconforming product control, and medical device reporting. Additionally, issues were noted with device history records and employee training documentation.