Vacunda & Design – FDA EIR, Sep 8, 2021

An FDA surveillance inspection of Vacunda & Design, a dietary supplement manufacturer and distributor in Camuy, PR, was conducted from August 17 to September 8, 2021. The inspection assessed compliance with Current Good Manufacturing Practices (cGMP) for dietary supplements under 21 CFR Part 111. The findings revealed significant and largely recurrent deviations, indicating a persistent lack of fundamental quality control.

Key violations included the absence of master manufacturing records, batch production records, and established product specifications for identity, purity, strength, and composition. The company also failed to assign batch or lot numbers to finished products and did not maintain written procedures for quality control operations, material review, reprocessing decisions, or the examination of finished product samples. Additionally, the inspection identified inadequate pest protection in the physical plant, lack of quality control for incoming components (e.g., expired raw material without documentation), uncalibrated instruments, and non-corrosion-resistant equipment.

Management, represented by the owner, acknowledged the observations and committed to implementing corrective actions within two weeks to six months, along with submitting a written response to the San Juan District Director. The recurrence of many critical violations from a previous 2013 inspection highlights systemic issues requiring urgent and comprehensive remediation to ensure product quality and consumer safety.