Max Chemical Inc. — 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)). Your firm uses water as a component in your over-the-counter (OTC) drug products. Your water system is not adequately qualified and monitored to ensure the system is operating properly, and continuously producing water suitable for its intended use. Water for pharmaceutical purposes must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. The lack of adequate validation provides no assurance the system performs as intended, and subsequent use of inadequately (b)(4) water in pharmaceutical manufacturing can adversely affect drug product quality and patient safety.

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 identity test on each shipment of each lot of components used in the production of your drug products, including the active ingredients (i.e., isopropyl and ethyl alcohol). Additionally, you relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers’ COAs for component specifications and characteristics. You also failed to determine whether each component conformed with all appropriate written specifications for purity, strength, and quality before using them. 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’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 firm failed to establish an adequate quality unit (QU) with responsibilities to ensure adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure: • Adequate finished product testing (21 CFR…