483
Health Pharma USA LLCFDA 483 - Health Pharma USA LLC - September 22, 2021
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An FDA inspection of Health Pharma USA LLC in Rahway, NJ, revealed significant deficiencies in laboratory controls, quality systems, production, and packaging. The firm failed to qualify working standards, maintain proper computer system controls, calibrate equipment, and adequately document laboratory and batch records. These issues indicate a lack of adherence to good manufacturing practices for drug products.
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ID · ab32da9f-e10a-4cef-bbb3-dbfad08ebda2