FDA 483 - MPP GROUP, LLC - June 07, 2024

During an inspection from June 5-7, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to MPP Group LLC, a contract laboratory in Mequon, WI. The document detailed several observations indicating lapses in adhering to regulatory standards for laboratory controls, specifically Current Good Manufacturing Practices (cGMP).

Key issues included the absence of a robust supplier qualification program, leading to the acceptance of reagent and standard analyses from suppliers without adequately establishing their reliability. Significant data integrity concerns were identified, including inadequate controls over electronic records for HPLC systems, the use of un-locked "draft" methods for GMP testing, reliance on unvalidated Excel spreadsheets for calculations, and insufficient review of original electronic data and audit trails. Furthermore, MPP Group LLC lacked formally approved test procedures for analyses such as pH and Visual Particulate Matter, instead referencing general USP chapters without specific, quality-approved, step-by-step guidance. Employee training was also found inadequate, with personnel qualified based on resume experience alone, lacking required technical training or practical challenge testing to verify their competency.

These observations indicate systemic weaknesses in MPP Group LLC's quality control and data management processes, necessitating prompt and thorough corrective actions to align their operations with cGMP regulations and ensure the reliability of their analytical services.