The regulatory notice highlights systemic deficiencies in the facility’s operational protocols. According to the company, FDA inspectors flagged concerns regarding environmental monitoring, equipment maintenance, and the rigor of internal investigation procedures. Despite the severity of the findings, the federal agency has not ordered a halt to production or requested a product recall at this time.

Amphastar officials confirmed they are treating the audit results as a priority. Management is currently developing a corrective action plan to bring the South El Monte site back into compliance with federal standards. The company maintains that operations remain uninterrupted while these adjustments are implemented.