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S & J International Enterprises Public Company Limited, a drug manufacturing facility in Thailand, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection in July 2023, resulting in adulterated drug products. The company's quality control unit failed to exercise adequate oversight and control over manufacturing operations and did not ensure products met established specifications for identity, strength, quality, and purity. Additionally, the firm delayed or limited FDA inspectors' access to and copying of records during the inspection, further violating the Federal Food, Drug, and Cosmetic Act. The company's response to the FDA's Form 483 observations was deemed inadequate as it lacked sufficient detail and evidence of corrective actions needed to achieve CGMP compliance.