FDA 483 - BioDuro, LLC - February 23, 2024

During an inspection from February 12 to February 23, 2024, the U.S. Food and Drug Administration (FDA) issued an FDA Form 483 to BioDuro, LLC, a drug manufacturer. This document outlines eight significant observations indicating deviations from Current Good Manufacturing Practices (CGMP).

The primary issues observed include a persistent failure to thoroughly investigate and identify the root cause of dissolution failures for a key drug product, despite ongoing rejections and deviations since 2022. The firm has not yet proposed a resolution to mitigate this quality risk. Furthermore, inspectors noted inadequate equipment design and maintenance, specifically a water system with visible green material in critical components.

Other observations include a lack of established written procedures, as master batch record parameters were not validated. Annual product reviews were found to be insufficient, failing to evaluate all quality standards or trend significant dissolution deviations. The firm also used an in-house dissolution test method that did not demonstrate equivalency to compendial standards and released drug product without proper testing. Critical quality control unit procedures were not followed, leading to the use of unqualified raw materials in commercial batches. Lastly, laboratory controls lacked scientific justification for clean hold times and insufficient acceptance criteria for related substances testing, as working standard solutions were not prepared in duplicate.

BioDuro, LLC is expected to provide a comprehensive response detailing corrective and preventive actions to address these serious compliance deficiencies and ensure the quality, safety, and efficacy of its manufactured drug products.