FDAnews
www.fdanews.com/articles/195422-ai-developer-algomedica-falls-short-on-capas

AI Developer Algomedica Falls Short on CAPAs

January 8, 2020

Algomedica’s Sunnyvale, California facility drew a Form 483 when an inspection revealed a pattern of failing to address the root causes of nonconformance of its artificial intelligence algorithm PixelShine that analyzes CT scans.

FDA investigators reviewed at least seven CAPAs that showed deficiencies in procedures such as verification of effectiveness, monitoring data corruption, and validating that CAPA actions did not adversely affect the finished devices.

During the inspection, the company said it had managed installations of the Pixel Shine software for evaluation by potential customers. But it did not have installation checklist documentation for any of the completed installations.

View today's stories