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A Florida hearing-aid manufacturer drew the FDA’s attention for various deficiencies observed during a May inspection, including inadequate procedures for responding to problems and complaints. Read More
The FDA cited three devicemakers for a range of deficiencies including inadequate procedures for device failures, MDRs, complaints, and recordkeeping. Read More
Six device manufacturing facilities landed Form 483s from the FDA after inspections turned up numerous problems with their CAPA, complaint, training and other procedures. Read More