# FDA 483 - BIALEX - December 17, 2018

Source: https://www.globalkeysolutions.net/records/483/bialex/fb11e374-5832-4d93-b884-573f643a6d39

> FDA 483 for BIALEX on December 17, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BIALEX
- Inspection Date: 2018-12-17
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: BIALEX, a medical device manufacturer in Tucson, AZ, was cited for a significant deficiency in its quality system related to external controls. The firm failed to establish procedures to ensure that all purchased or received products and services conform to specified requirements. Specifically, BIALEX has not evaluated current suppliers according to established procedures.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/bialex/ed0799d0-1c94-45ff-8003-ff9c331cb04d

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6