FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Canadian Devicemaker Nailed for Validation, CAPA Failures

Sept. 25, 2018
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Validation and CAPA failures were among quality system failures uncovered during a Feb. 26 to March 1 FDA inspection of Pega Medical’s Quebec facility.

Process validation activities failed to include acceptance activities or documented evidence of manufacturing conditions representative of routine production activities, the five-item Form 483 said.

The heavily redacted 483 noted that no acceptance criteria were established and no product testing was conducted for a product as part of the validation exercises for the company’s pediatric orthopedic devices, including 3D-printed orthopedic implants.

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