The FDA hit Genus Lifesciences with a Form 483 following a July inspection of its Allentown, Pa., drug facility, citing inadequate reviews of discrepancies and failure to reject substandard products. Read More
The FDA called out Bend Research for failing to adequately review discrepancies at its API facility in Bend, Oregon. Read More
Surgical instrument maker Biodex failed to report a medical device failure that resulted in a patient failing to the ground while being transported in an MRI stretcher that malfunctioned, according to a 483 that was issued following an A... Read More
Failure to report a voluntary recall to the FDA landed Respire Medical an FDA Form 483 following an April 24 to May 2 inspection at its Brooklyn, New York facility. Read More
300 N Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 – Fax (703) 538-7676 – Toll free (888) 838-5578.
Copyright ©2018. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing