FDA EIR - AAA Pharmaceutical, Inc. - April 03, 2019

An FDA surveillance inspection of AAA Pharmaceutical, Inc. in Lumberton, NJ, conducted from March 25 to April 3, 2019, identified significant Good Manufacturing Practice (GMP) non-compliances for its over-the-counter drug repacking and control laboratory operations. The inspection, guided by relevant compliance programs for drug repackers and OTC monographs, resulted in the issuance of a two-item FDA Form 483, Inspectional Observations. The primary violations included inadequacies within the quality control unit, where responsibilities and procedures were not fully documented or followed. Specific issues cited were the absence of a written procedure for sampling purchased bulk finished products, incomplete vendor assessments for certain suppliers, and insufficient detail in work instructions for mobile sampling booth operations. The inspection also found that changes to written procedures were not formally reviewed and approved by the quality control unit, exemplified by an open deviation from October 2018 where alternate test methods were used without proper procedural updates. Further verbal observations highlighted the lack of formal quality agreements with some bulk drug product vendors and the absence of a written system for material storage locations in the warehouse. The company is required to formally respond to the FDA's observations within 15 business days, detailing their corrective and preventive actions.