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.
Sterile devices were handled in a cleanroom with inadequately defined environmental controls, FDA inspectors found in an inspection of a Centurion Medical Products facility in Howell, Michigan. Read More
Failure to investigate complaints about devices that did not meet specifications and other serious quality system deviations landed Respire Medical Holdings an 11-item 483 following an FDA inspection of its Brooklyn, New York facility. Read More
The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison. The guidance applies to sponsors who wish to submit a 510(k) application using the agency’s Safety and Performance Based Pathway. Read More
The Tax Foundation, a Washington, D.C.-based think tank, called for the repeal of the 2.3 percent medical device tax introduced under the Affordable Care Act, finding that it would heavily impact the medical device industry. Read More
The FDA sent a warning letter to American Contract Systems for process validation violations at its Houston, Texas medical device manufacturing and sterilizing facility. Read More
Corrective actions by Integra Neurosciences may have affected the integrity of its external drainage systems and led to a cerebrospinal fluid leak, FDA inspectors found during an inspection of the firm’s Anasco, Puerto Rico plant. Read More
Environmental Tectonics: A litany of good manufacturing practices lapses related to documentation and validation resulted in a seven-item Form 483 for Environmental Tectonics following an inspection of its Southampton, Pennsylvania facility. Read More
Health Canada is creating a stand-alone Medical Devices Directorate (MDD) within its Health Products and Food Branch that will take a “lifecycle approach” and also take on postmarket functions currently within the Marketed Health Products Directorate Read More
Georgia’s Attorney General filed a complaint to temporarily stop Becton, Dickinson from operating its Covington medical device sterilization facility “in an unlawful manner.” Read More
Failure to validate equipment and to establish CAPA procedures were among the QMS failures discovered during an FDA inspection of contract manufacturer Custom Milling Center’s Golden, Colorado facility. Read More
Alt Medical Devices’ Miami, Florida plant lacked procedures to control labeling activities and procedures for maintaining device history records to show that its devices were re-labeled and re-packaged according to specifications, FDA investigators found. Read More
Lax process validation, inadequate control of nonconforming product and failure to implement CAPA procedures were a few of the concerns the FDA highlighted during an inspection of Mark Two Engineering’s Miami Lakes, Florida facility. Read More