Imprimis NJOF, LLC – FDA 483, Aug 18, 2026

From August 4 to August 18, 2026, the FDA inspected Imprimis NJOF, LLC, an outsourcing facility located in Ledgewood, New Jersey. The inspection, conducted under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, identified several significant concerns regarding the manufacture of sterile ophthalmic and injectable drug products. The primary violations centered on inadequate laboratory controls and flawed safety protocols. Specifically, the facility failed to establish scientifically sound standards for testing drug potency, purity, and stability, often releasing products without testing for impurities. Investigators also observed deficient cleanroom practices, such as improper sterilization of equipment and staff movements that could compromise sterile environments. Furthermore, the company failed to conduct thorough investigations into manufacturing failures, including the discovery of foreign fibers and bacterial growth in sterile areas. The Quality Control Unit was also criticized for failing to provide proper oversight, as they approved products despite missing data and equipment qualification errors. While these observations are not a final agency determination, the company is expected to respond to these findings. Required actions include submitting a written response to the FDA detailing corrective measures taken or planned, along with any objections to the observations, to ensure the facility meets professional safety and quality standards.