Outin Futures Corp. Warning Letter Details

Summary

Outin Futures Corp., a South Korean drug manufacturer, was found to have produced adulterated and misbranded finished pharmaceutical products, including "NEOGEN DERMALOGY AIRY SUNSCREEN Broad Spectrum SPF 50," due to significant Current Good Manufacturing Practice (CGMP) violations. The FDA inspection in March 2024 identified critical failures including incomplete laboratory records that did not document all test data necessary to ensure product compliance with specifications, as exemplified by out-of-specification results from repeated assays on sunscreen batch NJ09 that were not recorded in batch release documentation. The manufacturing deficiencies rendered the drug products unsuitable for introduction into interstate commerce under the Federal Food, Drug, and Cosmetic Act.