FDA 483 - Linatech, Llc - September 29, 2021

Linatech, Llc, a class II medical device manufacturer in Sunnyvale, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and follow procedures for complaint handling, servicing activities, document control, quality audits, and employee training. These issues indicate a systemic lack of control over critical processes for ensuring device quality and patient safety.