Colorful Products Corporation — FDA Warning Letter Findings

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 CFR211.22). Your firm manufactures over-the-counter (OTC) topical drug products such as (b)(4) and hand sanitizers 1 . Your Quality Unit (QU) did not provide adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to…

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements, and you failed to establish written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) & (b)). You have not…

Your firm failed to establish adequate 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 lacked appropriate process validation for your drug products. For example, you confirmed to our investigator that process validation was not performed for your (b)(4) or hand sanitizer drug products. In…

Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. (21 CFR 211.68(b)). Your firm lacked controls to assure the integrity of (b)(4) used in the manufacturing of your drug products. For example, your firm utilized software (i.e., (b)(4) ) for the retention of data, including your drug product formulations and the quarantine and…