Drugs

Multiple Violations at LeeSar Outsourcing Facility

A 4/29-5/9/2025 FDA inspection at the LeeSar drug outsourcing facility in Fort Myers, FL, found multiple violations in the firm’s production of compounded drugs. A just-released 11/21/2025 Untitled Letter lists these violations:

failure to meet the conditions of Section 503B, such as not placing the name of the drug on the label;
failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failure to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures;
failure to maintain written records so that the quality standards of each drug product can be evaluated at least annually to determine the need for changes in drug product specifications, manufacturing, or control procedures;
failure of the firm’s quality control unit to review and approve written procedures for production and process control, including any changes to them, designed to ensure that manufactured drug products have the identity, strength, quality, and/or purity they purport or are represented to possess; and
misbranded drug product violations.

FDA says it is unable to evaluate some of the firm’s proposed corrective actions due to the lack of supporting documentation, while other corrective activities appear deficient.

LeeSar was told to respond with a list of specific steps it has taken to address the violations in the letter, with documentation of its actions and a timetable for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome