Aromas Para El Alma S.A. — FDA Warning Letter Findings

Your firm also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). Your batch production records for your drug products do not include adequate production instructions, including but not limited to, identification of critical steps in your manufacturing processes such as critical parameters (e.g., (b)(4) and (b)(4) times) or the weight or volume of…

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)). You failed to conduct an adequate identity test on each shipment of each lot of components (including the ethanol active ingredient), used in the production of your drug products. You also failed to determine whether each component conformed with all appropriate written…

Your firm failed to establish adequate written production and control procedures for the charge-in of components designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.101). You failed to formulate your drug products with the intent to provide no less than 100% of the declared active ingredient. For example, your EREWHON drug products, EREWHON ANTIBACTERIAL SPRAY and EREWHON…

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your QU did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: • Adequate chemical and microbial testing and appropriate specifications for your finished drug products…