FDA 483 - Hercon Pharmaceuticals, LLC - April 05, 2019

Hercon Pharmaceuticals, LLC in Emigsville, PA, was inspected and cited for significant quality control and equipment management deficiencies. Observations included a failure to thoroughly investigate out-of-specification results for Nitroglycerin Transdermal System and not submitting a Field Alert Report. Additionally, the firm used unmonitored and improperly maintained freezers for reference standards and failed to calibrate manufacturing equipment across its full operating range.