American Cleaning Solutions — FDA Warning Letter Findings

Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and (b)). Your firm has not established that your processes used to manufacture hand sanitizer drug products are validated. You also confirmed…

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and (2)). You failed to adequately test your incoming components for identity before using the components to manufacture your drug products. Additionally, you relied on certificates of analysis from unqualified suppliers…

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 quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure the following: Appropriate testing for the identity and strength of the active ingredients was performed…

Your firm failed to establish and follow written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b). Your firm manufactures over-the-counter (OTC) hand sanitizer 1 drug products including Secure Gel Hand Rub and Secure Hand Rub, as well as non-drug products including insecticides and industrial cleaners. It is unacceptable as a matter of CGMP to continue manufacturing drugs using the same equipment that you use to manufacture pesticides or other…