483
Aurohealth LLCAurohealth LLC – FDA 483, Apr 11, 2019
Record Details
An FDA inspection of Aurohealth LLC in Lawrence Township, NJ, revealed significant deficiencies in equipment calibration and cleaning validation. The firm failed to ensure scales were appropriately calibrated for weighing raw materials and lacked adequate cleaning procedures and validation for manufacturing equipment, including transfer hoses. These issues raise concerns about the accuracy of drug product formulation and the prevention of cross-contamination.
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ID · f26e92cd-dc15-4e6c-828a-105e5f709bee
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