FDA 483 - AJES Pharmaceuticals, LLC - October 14, 2021

AJES Pharmaceuticals LLC, a dietary supplement manufacturer in Copiague, NY, was cited with five observations during an FDA inspection. The inspection revealed significant deficiencies in finished product testing, documentation of in-process specifications, laboratory control processes, and quality control procedures, including the release of out-of-specification products. These issues indicate a lack of adequate controls to ensure the identity, purity, strength, and composition of their dietary supplements.