FDA 483 - Vacunda & Design - September 08, 2021

An FDA inspection of Vacunda & Design in Camuy, PR, a manufacturer of dietary supplements, revealed ten significant observations, many of which were repeat violations from a 2013 inspection. The firm failed to establish and maintain essential manufacturing records, including Master Manufacturing Records and Batch Production Records, and lacked adequate quality control procedures and product specifications for its dietary supplements. Additionally, the facility exhibited poor pest control, uncalibrated equipment, and non-corrosion-resistant utensils.