FDA EIR - Pharmatech LLC - March 02, 2016

An FDA inspection of Pharmatech LLC, a manufacturer of prescription, over-the-counter drugs, and dietary supplements, was conducted from February 2 to March 2, 2016. The inspection, focusing on Current Good Manufacturing Practices (cGMP) for pharmaceutical and dietary supplement manufacturing, identified significant issues. A primary concern was the company's failure to address a recurring violation from a 2012 inspection regarding the integrity of analytical data from computerized systems. Despite previous observations and a promise of corrective action, no changes had been implemented. Additionally, the inspection identified several drug products, including Urin D/S, Hyoscyamine Sulfate Tablets, and Salsalate Film Coated Tablets, as potentially unapproved for market. The company was provided with relevant FDA guidance. Other verbal observations, discussed with management, included inaccurate laboratory equipment (pH meter thermometer), lack of timely quality assurance review for logbooks, and an ineffective change control management system that lacked adequate justification and periodic review. While no new formal inspectional observations (FDA-483) were issued during this inspection, the owner, Mr. Raidel Figueroa, acknowledged these findings and verbally committed to implementing corrective actions. These actions are expected to cover the long-standing computer system deficiencies, improve laboratory controls, enhance the change management program, and address the status of potentially unapproved drug products. The FDA indicated that future inspections would specifically verify corrections related to computerized systems.