Outin Futures Corp. — FDA Warning Letter Findings

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’s process validation and equipment qualification programs are inadequate. For example: The OTC drug product manufacturing process validation failed to evaluate the homogeneity of the API in the bulk…

Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products, including drug products manufactured, processed, packed or held under contract by another company. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit. (21 CFR 211.22(a) and…

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 laboratory records did not include complete data to support the analysis performed. For example, Neogen Dermalogy Day-Light Protection Airy Sunscreen product batch NJ09 were tested several times (i.e., re-test) for assay during batch release and stability study from September…

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 laboratory equipment used to generate analytical data for finished drug product release lacked restricted access and sufficient controls. There is no assurance that your systems have the appropriate controls to prevent data deletion and record…