FDA EIR - Armand Products Company - October 01, 2019

An FDA surveillance inspection of Armand Products Company, Inc., an active pharmaceutical ingredient (API) manufacturer in Muscle Shoals, AL, was conducted from September 10 to October 1, 2019. The inspection was performed under CP 7356.002F and ICH Q7 Good Manufacturing Practice (GMP) Guide for APIs, as the company manufactures USP grade potassium bicarbonate, which was identified as likely used in drug products by a customer, making it subject to current Good Manufacturing Practices (cGMP) per section 501(a)(2)(b) of the Act. The inspection resulted in an FDA Form 483, citing one primary observation: an inadequately designed, constructed, and maintained production system leading to contamination. Specifically, the firm's USP grade potassium bicarbonate was found to be contaminated with elemental impurities (corrosion metals like iron, aluminum, and zinc, referred to as "process scale") and physical contaminants (metal pieces, nuts, and bolts). These contamination issues, including frequent metal detector rejections during packaging, were known to management for at least two years, with insufficient corrective actions. The facility also exhibited numerous unaddressed cGMP deficiencies across quality systems, electronic data controls, labeling, laboratory controls, and preventative maintenance, as well as an insect infestation. Management acknowledged the issues and committed to written corrective actions, but declined to initiate a voluntary recall of affected product, despite concerns raised by the inspector regarding their risk assessment.