BEO Pharma Inc. dba BEO Pharmaceuticals Inc. — FDA Warning Letter Findings

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). You failed to perform adequate incoming testing of each component lot used in the manufacture of your over-the-counter (OTC) liquid drug products…

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)). You failed to adequately validate your manufacturing processes for all your OTC drug products and provide assurance that you are capable of consistently manufacturing a drug product with defined quality attributes…

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)). Release of Batch with Incomplete Finished Product Testing Your firm failed to establish an adequate quality unit (QU) to oversee the manufacture of your drug products. For example, your QU approved drug products for release without complete finished product testing. Your…

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Your firm failed to demonstrate that your microbiological test methods were appropriate to assure…