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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
Hansen Ophthalmic Development Lab, Inc., received a Form 483 for not establishing procedures for corrective and preventive action, and for not maintaining a complete device history record. Read More
CryoSurgery Inc. landed a Form 483 for poorly documented acceptance activities and inadequate procedures for ensuring the quality of received products. Read More
Customer Services Associates received a Form 483 for not developing written medical device reporting procedures, establishing procedures for corrective actions and reviewing complaints, and other violations. Read More
CryoSurgery Inc. landed a Form 493 for poorly documented acceptance activities and inadequate procedures for ensuring the quality of received products. Read More
Clement Clarke International Ltd. was cited for problems with its validation and acceptance procedures, supplier evaluations, and controls for nonconforming products. Read More
Audifon-USA established inadequate procedures for complaint reviews, corrective and preventive actions, equipment calibration, and other activities, according to a Form 483. Read More