Multiple repeat deficiencies related to medical device reporting, CAPAs, validation procedures and acceptance activities were uncovered during an FDA inspection of General Medical Company’s Jacksonville, Florida manufacturing facility. Read More
Failure to establish procedures for design control and to document control procedures and acceptance activity procedures were just a few of the 483 observations cited for device specification developer and repackager Web 2U Com during an inspection of its Fort Lauderdale, Florida plant. Read More
Westwood Laboratories didn’t establish corrective and preventive action procedures for nonconforming products, according to a 483 received following an inspection of the firm’s Azusa, California plant.
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