FDA EIR - Particle Technology Group, LLC - October 17, 2022

An FDA inspection of Particle Technology Labs, a contract laboratory specializing in particle characterization, was conducted from October 12 to October 17, 2022. Located at 555 Rogers St., Downers Grove, Illinois, the inspection aimed to assess compliance with drug manufacturing regulations, specifically FDA program 7356.002. The firm provides testing services for a range of industries, including pharmaceuticals (cGMP), food & beverage, and cosmetics, covering both Quality System and Laboratory System operations. The inspection did not result in the issuance of a formal FDA Form 483, indicating no significant deficiencies that would impact product quality were identified. However, one minor issue was verbally discussed with the company's management during the closeout meeting. This involved a testing sample found in the storage bin that was missing its sequential PTL ID number, likely due to a labeling printer misalignment. Particle Technology Labs’ management acknowledged this observation, emphasizing their understanding of the importance of verifying sample labeling in the order entry process. The firm was cooperative throughout the inspection, and no refusals or samples were collected.