FDA EIR - US Pharma Lab LLC - September 04, 2019

The Food and Drug Administration (FDA) conducted a surveillance inspection of US Pharma Lab Inc. in New Brunswick, NJ, on September 4, 2019. The company operates as an importer, distributor, and repacker of dietary ingredients. This limited-scope inspection was performed under MARCS OP ID 104733, adhering to the FY19 Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls in Human Foods Inspections (DFPG #19-03), specifically 21 CFR Part 117, and CPGM 7321.008 for Dietary Supplements. The inspection covered various aspects of the firm's operations, including administrative data, history, training programs, manufacturing/design operations, complaint handling, and recall procedures. A broad-based assessment of preventive controls under Subpart C of 21 CFR 117 was also conducted. Significantly, the inspection revealed no deficiencies. No FDA Form 483, "Inspectional Observations," was issued, and no issues were discussed with management during the closeout meeting. This outcome indicates that US Pharma Lab Inc. was found to be operating in compliance with the relevant regulatory requirements, and no corrective actions were required by the FDA. The firm maintains its FDA registration and handles dietary ingredients imported from countries such as India and China.