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A Cleveland, Ohio medical device manufacturer drew a Form 483 after the FDA’s January inspection found the firm’s procedures were inadequate. Read More
The FDA handed Endotec a Form 483 after a December inspection of its Santa Fe Springs, California facility brought to light validation failures and corrective and preventive action shortcomings. Read More
The company failed to submit a medical device report to the FDA for a patient who developed an infection at the incision site for the device. Read More
The FDA cited TriMed for numerous deficiencies such as faulty design control, inadequate design change procedures and incomplete risk analysis. Read More
The FDA flagged three U.S. facilities and two in Europe for a variety of deficiencies including CAPA failures and investigations of nonconforming products. Read More