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.
Mega Electronics, maker of the FemiScan Home Trainer incontinence device and the ME6000 biomonitor device, received an FDA warning letter for incoming inspection shortfalls and other quality issues. Read More
Invacare says it has made “significant progress” on its FDA consent decree, but must do some additional work on its complaint system before an independent auditor provides final certification to the agency. Read More
Epimed remanufactured products in response to complaints without established production and process control procedures, according to a Nov. 6 Form 483. Read More
Materialise USA had several calibrations on its preventive maintenance schedule, but did not perform them within seven days of the due date or document the reason for the delay, according to an FDA Form 483. Read More
Investigation failures related to debris/particulate matter associated with CareFusion’s Denver Ascites Shunt and percutaneous access kit led to a recent Form 483. Read More
American Aesthetics Medical Supply, a Dallas-based maker of microdermabrasion systems and crystals, lacks appropriate procedures for its suppliers and receipt of incoming ingredients, according to an FDA warning letter. Read More