FDA EIR - DSE Healthcare Solutions, LLC - April 30, 2018

An FDA inspection of DSE Healthcare Solutions, LLC, in Edison, NJ, was conducted from April 12 to April 30, 2018. This inspection served as a follow-up to a Warning Letter issued in March 2017, which cited significant Current Good Manufacturing Practice (cGMP) and labeling deficiencies for various dietary supplements. The regulatory framework for this inspection was Compliance Program 7321.008, focusing on Dietary Supplements and relevant sections of 21 CFR Part 111. The inspection revealed that DSE Healthcare Solutions had not fully corrected all previously identified issues. A primary violation noted was the company's continued failure to verify that each finished batch of dietary supplements conformed to established product specifications and label claims before distribution. This included not ensuring the reliability of data from contract manufacturers' certificates of analysis, not reviewing batch records, or performing independent product testing for products like Prelief and Urinozinc lines. Furthermore, several products, specifically Prelief caplets, Urinozinc Prostate Health Complex Plus Beta + Saw Palmetto caplets, and Urinozinc Prostate Health Complex Classic with Saw Palmetto capsules, were identified as unapproved and misbranded drugs due to therapeutic claims present on their labels, labeling, and company websites. Misbranding issues for Lydia Pinkham liquid products were still in the process of being corrected. However, DSE had addressed previous deficiencies related to investigating consumer complaints involving adverse events and establishing written procedures for quality control operations. At the conclusion of the inspection, an FDA-483, Inspectional Observations, was issued to DSE’s Vice President of Operations. The company is required to submit a written response detailing corrective actions for all outstanding deficiencies to the New Jersey District’s Compliance Branch within 15 business days.