FDA 483 - Auroactive Pharma Private Limited - June 26, 2026
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Auroactive Pharma Private Limited in Sancham Village, India, received a Form 483 with two observations related to significant deficiencies in their quality control laboratory. The firm failed to adequately investigate laboratory incidents involving HPLC injection variability and did not thoroughly investigate unexplained discrepancies, including a lack of clear definitions for "reanalysis" in their SOPs. These issues indicate systemic problems in their quality control and investigation processes.
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ID · 894f40b3-278e-49f5-b9c7-2b243d4c5853