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The FDA issued a Form 483 to Full Range Rehab citing problems with its CAPA procedures, acceptance activities, record-keeping and complaint handling. Read More
Three device manufacturing facilities landed Form 483s from the FDA after inspections turned up numerous problems with their CAPA, complaint, training and MDR procedures. Read More
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