We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Failure to submit medical device reports for its total parenteral nutrition bags landed the Metrix Company an eight-item Form 483 following a May 2016 inspection of its Dubuque, Iowa, facility. 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
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