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Nomax Inc. received a warning letter for failing to evaluate complaints, document corrective and preventive actions, and committing other violations. Read More
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