FDA 483 - CA-BOTANA INTERNATIONAL - April 04, 2025

CA BOTANA International, Inc. in San Diego, CA, an OTC drug manufacturer, received a Form 483 with five observations during an inspection from April 2-4, 2025. The inspection revealed significant issues with quality control, equipment qualification, laboratory controls, and component testing, many of which were repeated from a previous inspection. The firm failed to validate manufacturing processes, qualify equipment and water systems, investigate out-of-specification results, qualify contract testing laboratories, and test high-risk components like glycerin for impurities.