Bestco LLC – FDA EIR, May 17, 2019

An FDA surveillance inspection of BestCo, Inc., an Over-the-Counter (OTC) pharmaceutical manufacturer in Mooresville, NC, was conducted from May 13-17, 2019. The inspection assessed compliance with current Good Manufacturing Practices (cGMP) under Compliance Program 7356.002. The firm received a "Voluntary Actions Indicated" (VAI) classification with three main observations cited on an FDA Form 483. Key violations included inadequate written procedures for sampling temperature-controlled raw materials, a failure to complete 15 out of 30 required annual product reviews in 2018, and uncontrolled worksheets within master batch records lacking proper identification (headers/footers). The latter indicated a deviation from established production and process control procedures. Additionally, discussions with management highlighted areas for improvement, such as enhancing the deviation procedure for escalating recurring minor events, strengthening inventory systems to manage expired materials, updating laboratory procedures for reagent inventory verification, and placing greater emphasis on equipment maintenance. BestCo management committed to providing a response to the observations within 15 days, affirming their commitment to compliance with regulatory requirements.