FDA 483 - Enemeez, LLC dba Summit Pharmaceuticals - February 12, 2026

Between February 2 and February 12, 2026, the Food and Drug Administration (FDA) conducted an inspection of the Enemeez LLC manufacturing facility in Phoenix, Arizona. The resulting Form 483 highlights several significant failures to maintain quality standards and safety protocols under the regulatory framework of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Key violations centered on a lack of adequate quality control oversight. The firm notably shipped dozens of product batches before they were officially released by the quality department. There were also critical gaps in testing; for instance, the company did not perform required identification tests on raw materials used in over-the-counter drugs and failed to conduct proper studies regarding how long products can safely be held during the manufacturing process.

Furthermore, the inspection identified serious issues with laboratory procedures and investigations. The firm failed to thoroughly investigate instances where cleaning tests showed excessive bacterial counts and did not verify the testing methods used by their contract laboratories. Finished product testing was also improperly conducted on bulk tanks instead of final packaging, and cleaning validations did not check for residual cleaning chemicals.

While these observations do not represent a final agency determination, Enemeez LLC is expected to take immediate action. The company must provide a written response to the FDA detailing their corrective actions or any objections to the findings to ensure their manufacturing processes meet federal safety and quality requirements.