FDA WARNING_LETTER - Aromas Para El Alma S.A. - October 19, 2023

The FDA issued a Warning Letter to Aromas Para El Alma S.A. following an inspection from October 16-19, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. Specifically, EREWHON ANTIBACTERIAL SPRAY was cited as an unapproved new drug and both EREWHON HAND SANITIZER and EREWHON ANTIBACTERIAL SPRAY were deemed misbranded.

Key violations include: 1. **Inadequate Production and Control Procedures (21 CFR 211.101):** The firm failed to ensure drug products contained declared active ingredient levels. EREWHON products, labeled for 60% and 70% ethyl alcohol, were formulated with lower concentrations after a component change without proper assessment or validation, leading to subpotent batches. The firm's stated intent to recall was not acted upon, and the FDA publicly notified consumers of subpotent products. 2. **Incomplete Batch Production Records (21 CFR 211.188):** Records lacked critical manufacturing details like critical parameters and component weights/volumes, hindering reproducibility and quality assurance. 3. **Failure to Test Components (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm did not adequately test incoming components, including