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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
Pharmaceutical Innovations pled guilty to criminal and civil charges arising from its distribution of ultrasound gel contaminated with bacteria, according to the Department of Justice. Read More
General Medical Company, a maker of devices for excessive sweating, did not keep a record of verbal complaints and had problems with its complaint evaluations, the FDA found during an October 2015 inspection. Read More
Failure to validate equipment and computer software, and not establishing adequate procedures for implementing corrective and preventive actions, landed French devicemaker Eolane Vailhauques an FDA warning letter. Read More
FDA is warning healthcare providers of faulty filters used in Haemonetics’ Leukotrap RC System that are associated with higher than expected levels of leukocytes in transfused blood. Read More
The FDA is holding a public workshop Oct. 27 to Oct. 28 to discuss stakeholder input on refurbishing and reconditioning medical devices by third parties. Read More