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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
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