Chemical Services Group, Inc./Royal Chemical Company — FDA Warning Letter Findings

Your firm failed to establish acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release (21 CFR 211.165(d)). Your firm sampled in process material for the purpose of batch release testing which likewise did not include all appropriate tests to ensure that…

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) failed to provide adequate oversight of the manufacture of your OTC drug products. For example, your QU failed to ensure the following: Written procedures for equipment and facility cleaning, monitoring, and cleaning of…

Your firm failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(2)). Your firm relied on certificates of analysis (COA) from unqualified suppliers for your ethanol for specifications such as purity, strength, and quality. By not adequately analyzing your components for identity, purity, strength, and quality, you failed to ensure your incoming components meet appropriate specifications…

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your firm manufactured over-the-counter (OTC) hand sanitizer drug products 1 on equipment also used to manufacture industrial chemicals, including those for cleaning, polymer production, and paint additives. It is unacceptable as a matter of CGMP to manufacture drugs using the same equipment that you use to manufacture these non-pharmaceutical…