FDA 483 - Vitality Products International LLC - November 08, 2023

Vitality Products International LLC underwent an FDA inspection from November 7-8, 2023, at its Sarasota, Florida, warehouse and distributor facility. The inspection resulted in an FDA Form 483, detailing observations related to the company's operational procedures for its dietary supplement, Healus Complete Biotic, including operations at an off-site warehouse. The primary issues identified pertained to a lack of established written procedures. Specifically, the company had not developed written protocols for handling returned dietary supplements, including policies for acceptance or rejection and maintaining associated records. Furthermore, Vitality Products International LLC lacked established written procedures for its holding and distribution operations, failing to document these critical practices or maintain corresponding records. A third significant observation highlighted the absence of written procedures for reviewing and investigating product complaints, including a system for record-keeping related to complaint policies. These observations indicate areas where the firm needs to enhance its operational controls and documentation to ensure compliance with regulatory expectations for dietary supplement manufacturing and distribution. While the FDA Form 483 represents inspectional findings and not a final regulatory determination, the company is expected to implement prompt corrective actions to address these procedural deficiencies and ensure adherence to relevant quality system requirements.