LXR Biotech, LLC — FDA Warning Letter Findings

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). Your firm failed to conduct adequate release testing of (b)(4) drug product. You only conducted heavy metals and microbiological testing prior to batch release. Full release testing, which includes strength and identity testing of the active ingredient (e.g., (b)(4) ), must be performed before drug product batch release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that drug product batches conform to appropriate specifications before release.

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 drug products. For example, you failed to ensure: An adequate complaint handling process (21 CFR 211.198)…

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 failed to adequately qualify the equipment and validate the processes used to manufacture (b)(4) drug product. You have not performed process performance qualification (PPQ) studies, nor do you have a…

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)). Your firm contract manufactured an over-the-counter (OTC) (b)(4) drug product (e.g., (b)(4) ). You failed to conduct adequate testing on components used to manufacture this drug product. Additionally, your firm accepted components from suppliers without establishing the reliability of suppliers’ test analyses. You also did not routinely obtain or review the suppliers’ certificate of analysis (COA) for components (e.g., the active ingredient (b)(4) ). For instance, you provided only a certificate of conformance for your (b)(4) component. Without adequate testing, you do not have appropriate assurance that the components conform to appropriate specifications prior to use in the drug products you manufacture.