FDA 483 - Tanvex BioPharma USA, Inc - January 24, 2023

An FDA inspection of Tanvex BioPharma USA, Inc. in San Diego, CA, revealed significant deficiencies in cGMP procedures and records, quality oversight, and facility and equipment maintenance. Observations included inadequate labeling for storage conditions, inaccurate batch records, and failure to follow production procedures. Additionally, the firm lacked proper trending for its pest control program, failed to qualify a cGMP storage room, and exhibited poor microbial control and cleanliness in manufacturing areas.