We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
White Square Chemical failed to establish a design history file, complete a risk analysis, and committed other violations, according to investigators who handed the company a Form 483. Read More
Aesculap Inc. was cited in a Form 483 for neglecting to file timely medical device reportable (MDR) events and establish timely corrective and preventive actions in response to complaints. Read More
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