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.
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
Hong Kong’s Department of Heath issued safety warnings for Boston Scientific Ingevity MRI endocardial pacing leads and Percuflex Urinary Diversion stents, Draeger Medical GmbH Oxylog 3000 and Oxylog 3000plus ventilators, and Brainlab radiation treatment software, all of which may have manufacturing or production defects. Read More
Hoggan Scientific LLC was hit with a Form 483 after an inspection revealed a lack of adequate procedures for design control, corrective and preventive actions, complaint evaluation, and other issues. 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
Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention. Read More