FDA EIR - Bestco LLC - July 09, 2018

An FDA surveillance inspection of Bestco, Inc. took place on July 9, 2018, focusing on their manufacturing of dietary supplements and OTC drug products under Compliance Programs 7321.008 and 7303.803. While no formal inspectional observations (FDA Form 483) were issued, several significant issues were discussed with management. These included chipped production line rollers, numerous customer complaints regarding product hardness suggesting a need for additional testing, and deficiencies in complaint handling, such as incomplete third-party forms and a lack of customer contact information. Additionally, the firm was advised to maintain clearer records of employee re-training and to improve the clarity of returned goods dispositions. A notable finding involved a Class III recall in 2018 due to mislabeled dietary supplements, where the Vitamin D content on packaging did not match the actual formulation or batch record. Management committed to replacing equipment, enhancing testing methods, revising complaint and returned goods procedures, and ensuring proper re-training documentation. They were reminded of their ongoing responsibility to comply with the Federal Food, Drug, and Cosmetic Act.