FDA 483 - Eagle Labs Inc. - October 31, 2024

Eagle Labs Inc. was inspected by the FDA from October 3 to October 31, 2024, revealing several significant deficiencies in their manufacturing operations. The observations, detailed in a Form FDA 483, indicate a need for improved compliance with current Good Manufacturing Practices for dietary supplements. A key issue identified was the failure to establish comprehensive product specifications for identity, purity, strength, composition, and contamination limits for dietary supplement products. This was particularly critical for infant-intended products, which lacked specified contamination limits for bacteria like Clostridium perfringens and Cronobacter sakazakii.

Similar shortcomings were noted regarding component specifications, which also lacked adequate details for identity, purity, strength, and contamination limits. The inspection further cited the use of scientifically invalid methods for testing, specifically employing a non-scientific approach for identifying probiotic powders. Additionally, batch production records were incomplete, missing essential information such as the initials of personnel responsible for weighing, measuring, and verifying components. Eagle Labs Inc. must implement thorough corrective actions to address these observations, ensuring robust quality systems, valid testing methods, and complete documentation to meet regulatory requirements and safeguard product quality and safety.