FDA 483 - Siegfried El Masnou, S.A. - January 29, 2024

During an FDA inspection from January 22 to January 29, 2024, Dibar Nutricional S. de R. L. de C.V., a dietary supplement manufacturer and repacker in Tijuana, Mexico, was cited for multiple significant deviations from Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, as outlined in 21 CFR Part 111. Key issues included a profound lack of established written procedures for quality control operations, including material review, disposition decisions, and approval of processes. The firm also failed to establish comprehensive specifications for both raw materials and finished dietary supplement batches, which are critical for ensuring product identity, purity, strength, and composition. Furthermore, Dibar Nutricional did not perform identity testing on incoming dietary ingredients, relying instead on unverified supplier Certificates of Analysis. Significant deficiencies were noted in Batch Production Records (BPRs) for several products, which were incomplete and lacked essential details such as equipment identity, cleaning dates, component identifiers, yield statements, manufacturing step documentation, and packaging/labeling information. The firm also failed to establish written procedures for packaging and labeling operations, and BPRs did not include or reference finished product testing results. To achieve compliance, Dibar Nutricional must establish and follow robust quality control procedures, implement comprehensive specification setting and ingredient identity testing, develop complete and accurate batch production records, and create detailed written procedures for all packaging and labeling activities, ensuring adherence to 21 CFR Part 111.