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Inservco Inc. received a Form 483 for not establishing a complaint handling procedure, failing to properly maintain device history records, and other violations. Read More
Nuvasive received a Form 483 for failing to establish adequate corrective and preventive action (CAPA) procedures and failing to document process validation activities and results. 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