483 Suggests Disregard for FDA Procedures, Recordkeeping
An FDA inspection of Salt Lake City-based BioMeridian International found 16 observations — most in the form of missing procedures or documentation. Quality system procedures and instructions had not been established, and there were no management review procedures or designated management representative. The company had not performed an internal quality audit since spring 2007, the Form 483 states. BioMeridian’s complaint files were also found to be lacking, with no written procedures to ensure complaints were documented upon receipt, evaluated to determine if they needed to be reported to the FDA under MDR regulations and investigated when necessary. Device names and serial numbers were absent from the complaint files. Devices & Diagnostics Letter
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