Drugs

CGMP Issues at BEO Pharmaceuticals

A 10/16-11/4/2024 FDA inspection at the BEO Pharmaceuticals drug manufacturing facility in Brooksville, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/9 Warning Letter says specific violations were:

failure to test samples each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of component supplier’s test analyses at appropriate intervals;
failure to establish an adequate quality unit and failure to have in writing and fully follow the responsibilities applicable to the quality control unit;
failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess; and
failure 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.

FDA says the firm’s responses to the inspection observations were inadequate. The agency recommends that BEO retain a qualified consultant to assist it in meeting CGMP requirements.

BEO was told to correct violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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