483
AJES Pharmaceuticals, LLCFDA 483 - AJES Pharmaceuticals, LLC - November 21, 2022
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Record Details
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.
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ID · 343bb849-0e6e-48ce-9d93-e55be6a74f82