FDA 483 - BioDuro, LLC - September 06, 2019

Anchen Pharmaceuticals, Inc. in Irvine, CA, was cited for significant deficiencies in its manufacturing operations, particularly concerning laboratory controls and quality unit procedures. The inspection revealed issues with inadequate testing procedures for incoming materials and water hold times, as well as incomplete laboratory records for calculations. Furthermore, the firm failed to submit a required NDA Field Alert Report for a distributed product complaint and had an overdue investigation into foreign particles found during production.