FDA 483 - Merieux NutriSciences - April 25, 2024

During an FDA inspection from April 22-25, 2024, the unnamed firm received a Form 483 outlining significant deficiencies in its quality control and manufacturing practices. The inspection identified multiple violations under the Federal Food, Drug, and Cosmetic Act, particularly concerning Good Manufacturing Practices (GMP).

Key issues included a systemic failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results. Investigations often lacked scope, failing to extend to other affected batches or determine proper sample specifications. The firm also failed to initiate necessary investigations for microbial count results and inadequately invalidated OOSs.

Furthermore, laboratory controls were deemed deficient, with a lack of documented method suitability for microbial testing and absence of growth promotion testing for media. Data integrity was compromised due to inadequate computer system controls, including missing audit trail reviews, lack of audit trail functionality in electronic testing software, shared user credentials, and undefined user privileges. The Quality Control unit lacked written procedures detailing its roles and responsibilities, and GMP training for laboratory personnel was inadequate. The firm is required to respond to these observations with comprehensive corrective and preventive actions to ensure compliance with regulatory standards.