Kenil Healthcare Private Limited — FDA Warning Letter Findings

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 (21 CFR 211.67(a)). You failed to adequately clean and maintain your filling rooms and tube filling equipment used to manufacture your…

Your firm failed to have buildings used in the manufacture, processing, packing, or holding of drug products with adequate space for the orderly placement of equipment and materials to prevent mix-ups and contamination (21 CFR 211.42(b)). Your firm’s packaging and labeling operations are performed without adequate controls to prevent mix-ups and cross-contamination. For example, our investigators observed employees performing manual packaging and labeling operations on the…

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: Review and approval of written procedures for production and process controls that are…