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The FDA issued a warning letter to Thermedx, a Solon, Ohio-based manufacturer of gynecological and urological fluid management systems, for failing to notify the agency of device upgrades and other GMP violations. Read More
The FDA banned imports of Doro’s Evacu B wheeled stretchers for infants, after a Nov. 10 to 13, 2014, inspection found serious GMP violations that were noted in a Form 483 to the company. Read More
Internal audits can be a great way for a devicemaker to uncover quality issues and improve compliance programs, but there are challenges to doing them. The vast majority of manufacturers conduct internal audits soley because the FDA and ISO regulations say they should, says Susan Reilly, owner of the consultancy Reilly & Associates. That results in poorly conducted audits with little or no added value. During a recent FDAnews webinar, Reilly answered questions about how to design and perform effective internal audits.Read More
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