483
Hercon Pharmaceuticals, LLCHercon Pharmaceuticals, LLC – FDA 483, Apr 5, 2019
Record Details
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.
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