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For products that include a device component, sponsors must submit five-day reports, with supplemental or follow-up reports; malfunction reports; and correction or removal reports, as well as comply with recordkeeping requirements. Read More
Becton Dickinson Caribe received a Form 483 for its corrective and preventive action (CAPA), device acceptance, and process validation procedures. Read More
Precision Interconnect was hit with a Form 483 for poor corrective and preventive action (CAPA) procedures and failing to ensure that products conformed to requirements. Read More
Panoramic Corp. received a Form 483 for not reporting a correction and removal to the FDA and failing to submit medical device reports (MDRs). Read More