AnuMed International, LLC — FDA Warning Letter Findings

Your firm failed to establish 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)). Lack of Process Validation You failed to adequately validate your processes used to manufacture your drug products and demonstrate that your processes are reproducible and controlled to consistently yield drugs of uniform…

Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). You failed to perform adequate identity testing, including specific identity testing as appropriate, for each shipment of each lot of components, such as glycerin and ethyl alcohol (ethanol; alcohol), used in the manufacture of your drug products. During the inspection, you indicated that you were not aware testing was required and that you rely…

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)). You failed to validate your non-compendial microbial methods used to test drug products and assure…

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: • An adequate system for retention of production, control, or distribution records…