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

Source: https://www.globalkeysolutions.net/records/483/azaconsa-sl/a828b9a7-0403-42bf-b725-134b70d36108

> FDA 483 for AZACONSA S.L. on September 22, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AZACONSA S.L.
- Inspection Date: 2022-09-22
- Product Type: other
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/robert-w-calais/394ed883-caf9-43d2-9dd2-dab1d14f1a00)

Company: https://www.globalkeysolutions.net/companies/azaconsa-sl/064d60e6-1571-4e17-acd2-165f721d99b8

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1