Eagle Labs, Inc. – FDA EIR, Aug 24, 2023

An FDA inspection of Eagle Labs, Inc. in Oldsmar, FL, took place from August 21 to August 24, 2023. The inspection evaluated the company's adherence to regulatory standards for manufacturing, reviewing documentation such as batch records, stability data, and standard operating procedures. While no Form FDA-483, indicating formal observations, was issued, four significant areas for improvement were verbally discussed with management. These issues included the lack of FDA registration for a third-party coating company utilized by Eagle Labs, incomplete documentation on the “Coated Tablets QC Inspection” form, the absence of established written bulk hold times for materials, and general housekeeping practices regarding raw material storage in the warehouse. These points highlight areas where the company can enhance its Good Manufacturing Practices and strengthen its quality systems for both dietary supplements and drug products. No samples were collected, and the inspection concluded without any refusals.