MicroVention Costa Rica Has QS Issues

A 5/23-5/26/22 FDA inspection at MicroVention Costa Rica, in Alajuela, Costa Rica, found Quality System regulation violations in the firm’s manufacturing of microcatheters and balloon catheters. A just-released 9/30/22 Warning Letter says specific violations were:

• failing to verify a process that cannot be fully verified by subsequent inspection and test with a high degree of assurance and approved according to established procedures;
• failing to establish and maintain adequate procedures for implementing and maintaining corrective and preventive actions; and
• failing to adequately establish and maintain procedures to control product that does not conform to specified requirements.

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