Custom Assemblies, Inc. – FDA 483, Jul 19, 2019

Custom Assemblies, Inc. in Pine Level, NC, a medical device manufacturer, received a Form FDA 483 with three observations. The firm was cited for failing to adequately validate its bonding and quality control processes for tubing products. Additionally, the company did not submit required Medical Device Reports for leaking administration sets and lacked established procedures for finished device acceptance, specifically concerning sterilization validation.