Baxter Healthcare landed an FDA warning letter that includes multiple repeat observations and issues related to test methods, CAPAs and over-infusion with its elastomeric infusion systems. Read More

The FDA will create a device-only enforcement unit that promises more consistent inspections and enforcement decisions with fewer bureaucratic hurdles for investigators to issue warning letters. Read More

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

Baxter has received an FDA Form 483 for miscalculating the risk of a product issue. 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

Philips Healthcare’s failure to report a recall to the FDA earned the company an FDA warning letter. Read More