FDA EIR - SupraNaturals, LLC - June 09, 2016

An FDA inspection of SupraNaturals, LLC, a dietary supplement manufacturer in Springville, UT, was conducted from June 1-9, 2016. The inspection, which covered receiving, storage, blending, bottling, packaging, shipping, and laboratory operations, assessed the firm's compliance with Dietary Supplement Current Good Manufacturing Practices (21 CFR Part 111) and Domestic Food Safety regulations. The inspection revealed six formal objectionable conditions documented on an FDA-483. Key violations included the company's failure to verify that finished dietary supplement batches met product specifications for identity, purity, strength, and composition. Additionally, SupraNaturals lacked established written procedures for handling serious adverse events and did not consistently follow their product complaint investigation process. Quality control personnel had not reviewed or approved supplier qualification documentation, and no formal procedure existed for qualifying new suppliers. The firm also failed to adhere to its own written laboratory procedures, specifically regarding environmental testing when alert limits were exceeded, and did not maintain equipment through timely preventative maintenance. Lastly, written cleaning procedures for the physical plant were not consistently followed. Five additional issues were verbally discussed with management, such as undocumented corrective actions for CAPAs, unaddressed errors in batch records, and an absent water filtration system maintenance plan. CEO Thomas W. Mower committed to correcting all identified issues and providing a written response to the FDA within 15 business days, acknowledging potential regulatory sanctions.