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The FDA plans to unveil by Oct. 1 its own quality metrics for devicemakers based on three metrics from a pilot program conducted by Xavier Health and the Medical Device Innovation Consortium. Read More
Japan’s Mitaka Kohki failed to establish design control procedures, CAPA procedures, equipment calibration procedures, and documentation was found lacking for numerous critical processes during an inspection of the Tokyobased facility. Read More
Tosoh Bioscience, an importer of assays and high performance liquid chromatographs, failed to properly manage its suppliers and handle complaints, according to an FDA warning letter. Read More
Morris Innovative received a six-observation Form 483 for its handling of out-of-specification products, internal audits and corrective and preventive action plans. Read More
The FDA handed Zimmer Biomet Holdings a warning letter dated May 27, citing GMP non-conformities at the company’s facility in Montreal, Canada. Read More
The Centers for Medicare & Medicaid Services imposed sanctions on Theranos following a litany of quality control failures at the blood testing company. Read More
Several issues with CAPA investigations and change controls netted a warning letter for TYRX, a Medtronic subsidiary that makes absorbable antibacterial envelopes. Read More
Fluke Biomedical failed to properly select any of the suppliers for its CLEAR-Pb X-Ray shielding products, according to a five-observation Form 483. Read More