FDA 483 - Teyro Labs Private Limited - March 27, 2015

During an inspection conducted from March 23 to March 27, 2015, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Myers Vitamin, Inc., a dietary supplement manufacturer located in West Haven, Utah. The inspection revealed seven significant observations related to the company's adherence to Current Good Manufacturing Practice (cGMP) regulations for dietary supplements, as outlined in 21 CFR Part 111. A critical aspect of these findings is that all seven observations were repeat deficiencies from a previous inspection that concluded on July 10, 2013, indicating a persistent lack of compliance. The main issues identified included a failure to establish specifications for raw materials and finished dietary supplement products, meaning the company lacked defined standards for identity, purity, strength, and composition. Furthermore, Myers Vitamin, Inc. had not established or followed written procedures for critical quality control operations, including material review and disposition, and lacked Master Manufacturing Records and Batch Production Records for its products. The firm also failed to collect required reserve samples of packaged supplements and had no written procedures for handling product complaints. These observations highlight a systemic failure in the company's quality management system. To achieve compliance, Myers Vitamin, Inc. is required to implement robust corrective actions addressing these fundamental deficiencies in its manufacturing processes, quality control, and documentation practices. This is essential to ensure the safety, quality, and integrity of the dietary supplements it produces.