FDA Hits Devicemaker for Complaint Handling, Training, Records

October 13, 2017

Medicrea Technologies drew the FDA’s attention for inadequate complaint processing, employee training and material storage.

The devicemaker’s facility in Rillieux-la-Pape, France, received a Form 483 following a February inspection. Investigators found the company did not submit an MDR report within 30 days of becoming aware of information suggesting one of its products may have caused or contributed to death or serious injury.

The company received complaints about its products in March and July of last year, both of which were reported to the FDA as injury MDRs. The company made a total of nine MDR reports between Jan. 9 and Jan. 30 of this year based on complaints received between April and July 2016, and no corrective actions were taken to cut down on reoccurrence of the reporting problems.

The form also faulted the company for its complaint investigations, which did not sufficiently investigate incidents involving possible failures of devices to meet any of their specifications. Complaint records for surgical instruments did not feature the devices’ usage histories.

The company also found inadequate procedures for acceptance of incoming products, and that Medicrea did not regularly evaluate all suppliers to ensure that its received products were within specification. One of its suppliers of surgical instruments had not been evaluated since its initial acceptance as a supplier.

Lastly, the investigators found the company’s design verification for certain products did not confirm design output met design input requirements, and did not properly explain these nonconformities. The company promised to correct all five FDA observations.

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