FDA 483 - Nutritional Sales and Customer Service, LLC - July 31, 2024

During an inspection from July 8 to July 31, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Nutritional Sales and Customer Service, LLC, a dietary supplement manufacturer. The report highlighted critical deviations from regulatory requirements, many of which were repeat observations from previous inspections in 2013, 2018, and 2021. The primary issues involved significant gaps in quality control and testing processes. Specifically, the firm failed to conduct appropriate identity tests for dietary ingredients prior to use, such as various lots of (b)(4) and (b)(4). Additionally, the company did not qualify its suppliers by independently verifying the accuracy of their certificates of analysis for ingredient purity and composition, relying instead on unconfirmed supplier data. Finally, Nutritional Sales and Customer Service, LLC did not perform necessary testing to ensure that finished dietary supplement batches, including products like (b)(4) and (b)(4), met established specifications for identity, purity, strength, and composition. These observations indicate a persistent lack of adherence to manufacturing standards under the Federal Food, Drug, and Cosmetic Act. The company is expected to promptly address these findings and implement comprehensive corrective actions to resolve the identified deficiencies.