FDA 483 - Linatech, Llc - November 08, 2019

Linatech, Llc, a repackager/relabeler in Sunnyvale, CA, was cited for numerous deficiencies in its quality system during an FDA inspection. The firm failed to establish adequate procedures for complaint handling, management reviews, quality planning, corrective and preventive actions, document control, and servicing activities. These issues indicate a fundamental lack of a robust quality management system.