Procaps S.A. – FDA EIR, Apr 8, 2019

An FDA inspection of Procaps S.A., a foreign dietary supplement and pharmaceutical drug manufacturer located in Barranquilla, Colombia, was conducted from April 4-8, 2019. This initial dietary supplement inspection focused on the firm's softgel capsule manufacturing and quality control processes. The regulatory framework for the inspection included compliance programs 7321.008 and 7321.005, pertaining to dietary supplements and general food labeling requirements. Procaps S.A. exports 11 varieties of bulk softgel dietary supplements to the United States, with approximately $870,000 USD in sales to the U.S. in the preceding year. The main issue identified during the inspection was a verbal observation that the firm's bulk packaged dietary supplement labels lacked essential information, specifically a net quantity statement, an ingredient list, and the name and address of the manufacturer or distributor. No FDA Form 483 was issued. As a required action, Procaps S.A. management was asked to submit corrected labeling for FDA review. The company promptly responded by providing copies of new corrected bag and box labels, along with associated employee training records, demonstrating their commitment to addressing the observation.