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

An FDA inspection of Eagle Labs Inc. in Seminole, FL, was conducted from October 3 to October 31, 2024. The comprehensive inspection, initiated due to a consumer complaint and general surveillance, focused on the company's dietary supplement manufacturing operations, governed by 21 CFR Part 111 (Current Good Manufacturing Practice). The inspection revealed several significant violations.

Key issues included the company's failure to establish complete product specifications for identity, purity, strength, composition, and contamination limits for dietary supplements. Notably, infant-intended products lacked necessary testing for pathogens like Clostridium perfringens and Cronobacter sakazakii. Similar deficiencies were identified in specifications for dietary supplement components. Furthermore, Eagle Labs did not ensure that all tests used to verify specifications were scientifically valid, and their batch production records were incomplete, missing critical information such as initials for weighing and verifying components.

Management acknowledged these findings and indicated plans to update product and component specifications and correct batch production records. A formal written response to the issued Form FDA 483 is required within 15 business days to address these deficiencies and avoid potential legal sanctions.