FDA EIR - BioDuro, LLC - September 06, 2019

An FDA inspection of Anchen Pharmaceuticals, Inc. in Irvine, CA, was conducted from September 3-6, 2019, as a surveillance and Drug Quality Reporting System (DQRS) inspection, following cGMP regulations. The inspection identified several significant issues, leading to a four-item Form FDA-483. Main violations included the company's inadequate testing procedures for incoming active pharmaceutical ingredients (APIs), specifically Bupropion HCl USP, which repeatedly led to particulate contamination and product rejections. Additionally, the firm had not established a hold time for purified water used in manufacturing. Laboratory records were found deficient, lacking complete documentation of all calculations, such as those for system suitability standards in dissolution analysis. Anchen also failed to submit a required NDA-Field Alert Report within three working days after discovering black particles in a distributed batch of Bupropion HCl ER tablets, a failure attributed to an insufficient re-evaluation of the issue. Finally, the Quality Assurance unit did not consistently follow its procedures for closing deviation reports, leaving critical investigations open and sources of contamination undetermined. Three verbal observations also highlighted the absence of defined limits for "technically unavoidable particles," calibration program gaps, and insufficient electronic audit trail review documentation. Management committed to providing a written response with corrective actions within 15 business days to address these regulatory deficiencies.