FDA EIR - Dynalabs LLC - September 26, 2019

An FDA inspection of DYNALABS LLC, a contract testing laboratory for compounded pharmaceutical products in Saint Louis, MO, was conducted from September 9 to September 26, 2019. This inspection, carried out under the framework of Drug Manufacturing Inspections (CP 7356.002), focused on the analytical and microbiological laboratory operations of the voluntarily registered drug establishment. The inspection resulted in the issuance of a 4-item FDA Form 483, detailing several critical deficiencies. These violations included the failure to establish accurate, specific, and reproducible test methods, and the inadequate use of reliable methods for making stability-indicating claims. Furthermore, DYNALABS LLC failed to properly record and justify deviations from established specifications, standards, and procedures. A significant issue was also identified regarding the quality control unit's responsibilities, as procedures were not fully written or consistently followed. The findings led to an "Official Action Indicated" classification, signifying that the firm's practices were not in compliance with regulatory standards. In response, DYNALABS LLC committed to providing a written response to the FDA within 15 business days, outlining their proposed corrective actions to address these serious observations, indicating a requirement for comprehensive improvements to its quality systems and laboratory practices.