FDA 483 - First Call, Inc. - July 19, 2019

First Call, Inc., a manufacturer of the Class II Suturing Washer device in Winona Lake, IN, was cited for multiple quality system deficiencies during an FDA inspection. Observations included the failure to establish a design history file, inadequate procedures for supplier quality, lack of Unique Device Identifier (UDI) in device history records, and a lack of independence in internal quality audits. These issues indicate significant non-compliance with medical device quality system regulations.