FDA EIR - DSE Healthcare Solutions, LLC - August 25, 2016

An FDA inspection of DSE Healthcare Solutions, LLC, conducted from August 9 to August 25, 2016, revealed significant deficiencies in the company's dietary supplement operations. This first inspection of DSE identified multiple violations of the Dietary Supplement Regulation (21 CFR Part 111), particularly concerning quality control, batch records, and complaint handling. Major issues included the company's failure to verify whether finished batches of dietary supplements, such as Prelief, Lydia Pinkham, and Urinozinc products, conformed to established product specifications. DSE also did not formally approve the release of finished batches into interstate commerce, relying instead on contract manufacturers. A notable absence was written procedures detailing the responsibilities of quality control operations. Furthermore, the company failed to investigate numerous consumer complaints, including Serious Adverse Events, for products like Urinozinc Prostate Plus, Prelief, Urinozinc, and Charcocaps. Labeling and product composition issues were also cited. Charcocaps capsules contained Activated Charcoal and Lydia Pinkham Herbal Liquid contained Salicylic Acid, neither of which are recognized dietary ingredients. Additionally, some Prelief bottles lacked Supplement Facts Panels, and labeling on various products and the company's websites made claims that could misbrand dietary supplements as unapproved drugs. At the conclusion of the inspection, an FDA-483 was issued, and DSE management was instructed to submit a written response to the New Jersey District's Compliance Branch within 15 business days, detailing corrective actions for all identified deficiencies.