Aromas Para El Alma S.A. Warning Letter Details

Summary

Aromas Para El Alma S.A., a Costa Rican drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, resulting in adulterated drug products. The company failed to establish adequate written production and control procedures for component charge-in, and produced unapproved new drugs including EREWHON ANTIBACTERIAL SPRAY, which was introduced into interstate commerce without FDA approval. Additionally, EREWHON HAND SANITIZER and EREWHON ANTIBACTERIAL SPRAY were misbranded products. The violations were documented during an FDA inspection conducted from October 16-19, 2023, and the company's November 2023 response to the Form FDA 483 was reviewed but found inadequate to address the significant CGMP deficiencies.