Kilitch Healthcare India Limited — FDA Warning Letter Findings

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your firm failed to collect the required amount of environmental and personnel monitoring samples required by your procedures to support the manufacture of sterile drug products. During the inspection, a reconciliation of samples that should have been taken during manufacturing…

Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)). Environmental Monitoring Deficiencies Your environmental monitoring (EM) program is deficient. Locations selected for EM in critical areas such as the ISO 5 aseptic processing line, do not have scientific justification to…

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’s QU failed to adequately execute its responsibilities. For example: A. Your QU failed to follow approved, written production and process controls. Your firm was manufacturing Multi Action Relief Drops, Polyvinyl Alcohol 0.5%, Povidone…