AZACONSA S.L.September 22, 2022

FDA 483 - AZACONSA S.L. - September 22, 2022

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Record Details

An FDA inspection of AZACONSA S.L. in Novelda, Spain, revealed significant deficiencies in their dietary supplement manufacturing processes. The firm failed to establish proper identity specifications for components and did not verify finished product specifications for microbiological contaminants. Additionally, the company did not collect and hold required reserve samples of distributed dietary supplements.

Company: AZACONSA S.L.
Inspection Date: September 22, 2022
Product Type: Other
Office: Office of Biological Products Operations - Division I
Person: Robert W. Calais (investigator)

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ID · a828b9a7-0403-42bf-b725-134b70d36108