483
Aurolife Pharma LLCAurolife Pharma LLC – FDA 483, Aug 26, 2022
Record Details
An FDA inspection of Aurolife Pharma LLC in Durham, NC, from August 22-26, 2022, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company's CAPA process failed to ensure the effectiveness of actions taken and did not adequately consider their potential adverse effects on finished products. This indicates a moderate severity issue related to quality system controls.
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ID · a5413264-1418-4ddc-ae62-3dadbcc49db5
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