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The FDA issued Form 483s to seven device facilities for a range of deviations including noncompliance with their SOPs and problems with complaints and equipment maintenance. Read More
The FDA cited Jensen Industries, Tyson Bioresearch, OsteoSymbionics and Innovative Sterilization Techniques over problems with their CAPA procedures, complaint handling and MDRs. Read More
Five device manufacturers landed Form 483s from the FDA over their handling of complaints, medical device reporting, and corrective and preventive actions, among other deviations. Read More
The FDA issued Form 483s to Jensen Industries, Tyson Bioresearch, OsteoSymbionics and Innovative Sterilization Techniques, citing problems with their procedures for corrective/preventive actions, complaints and MDRs. Read More
The FDA issued a warning letter to contact lens manufacturer The See Clear Company, citing problems with its complaint and corrective action procedures. Read More
Companies most likely to benefit from the Medical Device Single Audit Program will include those selling products in Canada, along with manufacturers of finished medical devices and high-risk devices, said MDSAP expert Brian Ludovico, in an FDAnews webinar. Read More
Repro-Med Systems in Chester, N.Y. failed to submit a report to the FDA on steps taken to reduce a health risk posed from a device, inspectors found during a late 2016 inspection. Read More