Compania Embotelladora del Fuerte,S. de R.L. de C.V. – FDA EIR, Aug 20, 2018

An FDA comprehensive inspection was conducted at Compania Embotelladora del Fuerte, S. de R.L. de C.V., a foreign food manufacturer, on August 20, 2018. This initial inspection by the FDA evaluated the firm's operations related to bottled soft drinks, specifically Coca Cola brand 500 ml glass containers. The scope included assessment of receiving, storage, processing, sanitation, distribution, and record-keeping practices. The inspection was performed in accordance with the regulatory framework of Compliance Program 7303.803, the Domestic Food Safety Program, and CPGM 7321.005, which covers Domestic and Import NLEA, Nutrient Sample Analysis, and General Food Labeling. Notably, the inspection concluded with "No Action Indicated" (NAI). No deviations or issues were observed by the FDA inspector, and consequently, an FDA Form 483, 'Inspectional Observations,' was not issued. There were no samples collected, and no refusals were encountered during the inspection. Therefore, no specific corrective or required actions were mandated for the company following this inspection, reflecting full compliance with the evaluated regulatory standards.