A federal court this week entered a consent decree against a Pennsylvania compounder for manufacturing purportedly sterile drugs in insanitary conditions. Read More
The FDA issued a warning letter to Akorn’s sterile drug manufacturing facility in Decatur, Illinois on Jan. 4 over poor aseptic conditions observed during an inspection last spring. Read More
The FDA flagged Stand Aid of Iowa in a Form 483 over shoddy document control, device history records and documentation of nonconforming product activities seen at its Sheldon, Iowa facility during an Oct. 22-23, 2018 inspection. Read More
The FDA hit Imaging Biometrics with a Form 483, calling the Elm Grove, Wisconsin healthcare software developer out for its medical device reporting procedure and complaint records. 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 ©2019. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing