Natuzen Co., Ltd. — FDA Warning Letter Findings

Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Your firm manufactures OTC drug products including Atoren Hand Sanitizer. 1 Based on the records and information you provided, you did not demonstrate that you are testing your active ingredient ethanol for methanol. For example, you stated that hand sanitizers containing ethanol are not tested for methanol in accordance with a “notification of the…

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). The records and information you provided did not demonstrate that you have established an adequate quality unit (QU) to oversee the quality of your drug manufacturing operations. In your response, you state that “We…

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). The records and information you provided did not demonstrate that you have established adequate, validated procedures for cleaning of non-dedicated manufacturing equipment. Cleaning validation cannot be conducted without specific, reproducible cleaning procedures. Inadequate removal of active ingredients and product residues from surfaces of non-dedicated manufacturing equipment can lead to contamination of drug products subsequently manufactured on that equipment.