FDA 483 - ARG Laboratories, Inc. - September 20, 2023

ARG Laboratories, Inc., an OTC drug manufacturer, was subject to an FDA inspection from September 11-20, 2023. This inspection, conducted under the Federal Food, Drug and Cosmetic Act, identified critical deficiencies indicating non-compliance with Good Manufacturing Practices (GMP) for drug production.

Key violations included a severely inadequate quality control unit, lacking sufficient authority, resources, and documented procedures, with one person performing conflicting quality and production roles. Alarmingly, the firm released numerous drug products, such as those containing Octocrylene, Camphor, and Menthol, despite failing their active ingredient assay specifications.

Further observations highlighted an absence of validated manufacturing processes, including equipment cleaning for shared drug/cosmetic lines and a critical water system that lacked purity and microbiological quality testing. Laboratory controls were insufficient, with no established specifications or test procedures for raw materials or finished products. The company relied on supplier certificates without identity testing, used unverified 'laboratory samples,' and even incorporated industrial-grade and expired raw materials into drug products. Additionally, drug product expiration dates were not supported by appropriate stability data.

ARG Laboratories, Inc. is now required to develop and implement comprehensive corrective actions to address these serious observations and bring its operations into compliance with regulatory requirements for drug manufacturing.