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GMP violations including failure to submit a premarket approval application for its denture liner and failure to register the device in 2015 prompted an FDA warning letter to Better Health Systems. Read More
The FDA hit Smith & Nephew with a warning letter for quality, CAPA and procedural issues related to its Truclear Ultra Reciprocating Morcellators 4.0. Read More
The FDA handed Siemens Healthcare Diagnostics a Form 483 for violations including inadequate documentation of corrective actions and substandard complaint-handling procedures. Read More
The FDA handed Quality Electrodynamics a warning letter for poor complaint handling, CAPA and validation practices, including failure to adequately validate suppliers. Read More
British devicemaker EMcision received an FDA warning letter for medical device reporting failures, inadequate CAPA procedures and other issues. Read More
The FDA hit Smith & Nephew with a warning letter for quality, CAPA and procedural issues related to its Truclear Ultra Reciprocating Morcellators 4.0. Read More
Manufacturers planning to participate in the Medical Device Single Audit Program should first study up on Australian and Brazilian regulations, an official at the first company to go through a MDSAP audit says. Read More
Device failures and inadequate complaint handling procedures resulted in a Form 483 for Biogenex Laboratories, a maker of automated molecular pathology workstations. Read More