American Chemet Corporation – FDA EIR, Jun 30, 2020

An FDA-contracted state inspection of American Chemet Corporation’s East Helena, MT facility occurred on June 30, 2020. The inspection aimed to assess the company's compliance with current Good Manufacturing Practices (cGMP) under Title 21 CFR Part 507 of the Food Safety Modernization Act (FSMA) for animal feed ingredients. American Chemet Corporation manufactures cupric oxide for animal feed and maintains an active FDA food facility registration. The inspection yielded positive results, with no FDA-483 (Inspectional Observations) issued, indicating an absence of significant violations or issues. A previous labeling concern from a 2015 inspection was noted as corrected. All operational areas reviewed, including personnel hygiene, facility upkeep, sanitation, water systems, equipment, and manufacturing protocols, were deemed satisfactory. The company also demonstrated adequate procedures for complaints, recalls, and product traceability using lot codes. While no specific violations or mandatory corrective actions were documented, management was advised to further examine compliance with the Hazard Analysis and Risk-based Preventive Controls subpart of the FSMA regulations. No samples were collected, and no voluntary corrections were required.