QS Violations at Flextronics America

A 10/20-10/30/2025 FDA inspection at the Flextronics America facility in Austin, TX, found Quality System Regulation violations in the firm’s manufacturing of a continuous glucose monitor. A 1/27 Warning Letter says the specific violations were:

• failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure; and
• failure to adequately establish and maintain procedures for implementing corrective and preventive action.

The letter says the firm’s responses to the inspection observations were inadequate. Flextronics was told to act promptly to correct the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of each action, and a schedule for completing the corrections.