Global Pharma Healthcare Private Limited — FDA Warning Letter Findings

Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods, and you also failed to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile conforms to such requirements (21 CFR 211.165(e) and 211.167(a)). Your firm lacked adequate sterility testing, for example: A. You failed to show that your sterility test method was suitable to detect microorganisms in your…

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 the responsibilities and authority to oversee the manufacture of your drug products. For example: A. You failed to perform adequate batch release to ensure the acceptability of all…

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Inadequate Equipment and Processes A. You lacked adequate scientific evidence that the aseptic filling machine used for manufacture of Artificial Tears was suitable for its intended use. Your qualification report…

Your firm failed to establish a system for monitoring environmental conditions in aseptic processing areas and an adequate system for cleaning and disinfecting the room to produce aseptic conditions (21 CFR 211.42(c)(10)(iv) and 211.42(c)(10)(v)). Sterilization and Cleaning You failed to adequately sterilize and clean your equipment used for drug product manufacturing, for example: A. You failed to ensure that all equipment with direct product contact was sterilized. During…