Clean Solutions LLC — FDA Warning Letter Findings

Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). You failed to validate the processes used to manufacture your drug products. You also failed to qualify the equipment used to manufacture your drug products. Process validation evaluates the soundness of design and state of…

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: • Establishment of adequate procedures describing complaint handling, change control, and…

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 211.84(d)(2)). Your firm manufactures over-the-counter (OTC) topical drug products, such as antibacterial hand soaps containing benzalkonium chloride. You failed to perform adequate identity testing of each component lot used in the manufacture of your drug products. You also relied on your suppliers' certificate of analysis (COA) without establishing the reliability of your component suppliers' test analyses at appropriate intervals. Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before use in the manufacture of your drug products.

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and conduct for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)). Your firm failed to perform appropriate testing on your hand sanitizer and antibacterial hand soap drug products prior to release for distribution. Specifically, during the inspection, you stated that no chemical or microbiological analyses are performed on your finished drug products. Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Because you lacked adequate testing of each batch of your drug products, you do not know whether they conform to all appropriate finished product specifications and are suitable for release to consumers.