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.
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
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