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Failure to establish corrective and preventive action procedures as well as procedures for receiving and reviewing complaints landed Texas-based Simpro an FDA warning letter. Read More
The International Medical Device Regulators Forum’s single-audit program remains on track for full implementation in 2019, and companies should be shoring up their internal auditing processes to prepare. Read More
Collagen Matrix has received a warning letter after the FDA found cGMP violations and quality system issues with its devices for use in oral/maxillofacial, neurosurgery and orthopedic-spine surgery. Read More
Failure to report a design change and to conduct proper design validation for its porcine xenograft particulate in syringe landed Collagen Matrix an FDA warning letter. Read More
Failure to establish corrective and preventive action procedures as well as procedures for receiving and reviewing complaints landed Texas-based Simpro an FDA warning letter. 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
TriMed, a maker of implantable bone fixation systems, failed to report a device failure that required surgery to remove the device, according to an FDA warning letter. Read More