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Home » Missouri Specification Developer Gets Form 483 for Complaint Handling Issues, Lack of Design Controls
Missouri Specification Developer Gets Form 483 for Complaint Handling Issues, Lack of Design Controls
Missouri-based Hi-Dow International, a manufacturer of transcutaneous nerve stimulators (TENS) units, received a form 483 for several repeat observations of failure to establish proper complaint procedures, lack of design controls, and inadequate procedures for corrective and preventive actions, among other lapses.
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