FDA 483 - AJES Pharmaceuticals, LLC - November 21, 2022

AJES Pharmaceuticals, LLC, a dietary supplement manufacturer in Copiague, NY, received a Form 483 with five observations, including repeat findings. The inspection revealed significant deficiencies in finished product testing, laboratory controls for reference standards, equipment cleaning and maintenance, and record-keeping for master and batch manufacturing. These issues indicate a lack of adequate quality control and adherence to good manufacturing practices.