Anaheim, California-based Anacom MedTek hadn’t established procedures for finished device acceptance, for acceptance of incoming product or for CAPA activities, an FDA inspection found. Read More

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

The FDA cited six devicemakers for a range of GMP and other failures, including root-cause analysis for nonconforming products and lax environmental controls. 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. Read More

An FDA inspection of Medical Informatics’ Houston, Texas facility revealed lax complaint handling and a lack of medical device reporting procedures. 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. Read More

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