483
CA-BOTANA INTERNATIONALFDA 483 - CA-BOTANA INTERNATIONAL - November 12, 2019
Record Details
CA Botana International, Inc. in San Diego, CA, an OTC drug manufacturer, was cited for significant quality control and manufacturing deficiencies during an FDA inspection. The firm released out-of-specification drug products, used expired active ingredients, and lacked proper validation for equipment and cleaning processes. These issues indicate a systemic failure in ensuring product quality and safety.
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