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Algomedica’s Sunnyvale, California facility drew a Form 483 when an inspection revealed a pattern of failing to address root causes of nonconformance of its artificial intelligence algorithm PixelShine that analyzes CT scans. Read More
The FDA slapped Henan Kangdi Medical Devices with a warning letter over repeat CGMP failures at its Zhoukou, Henan facility, including a lack of testing.
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The firm had no system in place that checked the effectiveness of CAPAs, and no corrective action was taken for out of range temperatures in storage areas. Read More