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The agency found a lack of evidence that customers used the devices solely for forensic and R&D purposes, as required by their instructions for use. Read More
Numerous documentation lapses were observed for corrective and preventive action procedures, including missing signatures and risk assessments of CAPA actions, the agency said. Read More
The FDA hit six devicemakers for a range of compliance failures observed during facility inspections, including lax acceptance procedures and missing records. Read More
Georgia’s Attorney General filed a complaint to temporarily stop Becton, Dickinson from operating its Covington medical device sterilization facility “in an unlawful manner.” Read More
Failure to validate equipment and to establish CAPA procedures were among the QMS failures discovered during an FDA inspection of contract manufacturer Custom Milling Center’s Golden, Colorado facility. Read More
Alt Medical Devices’ Miami, Florida plant lacked procedures to control labeling activities and procedures for maintaining device history records to show that its devices were re-labeled and re-packaged according to specifications, FDA investigators found. Read More
Lax process validation, inadequate control of nonconforming product and failure to implement CAPA procedures were a few of the concerns the FDA highlighted during an inspection of Mark Two Engineering’s Miami Lakes, Florida facility. Read More