# FDA 483 - Azzur Labs - San Diego LLC - August 19, 2022

Source: https://www.keypedia.com/records/483/azzur-labs-san-diego-llc/eaed3855-38ea-4f4f-9dcc-d97a920658ee

> FDA 483 for Azzur Labs - San Diego LLC on August 19, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Azzur Labs - San Diego LLC
- Inspection Date: 2022-08-19
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Azzur Labs - San Diego LLC, a control testing laboratory, received an FDA Form 483 citing significant deficiencies in quality control and laboratory operations. The firm failed to ensure proper review of environmental monitoring calculations and raw data by the Quality Department. Additionally, observations included a lack of scientific justification for decontamination procedures and hold time studies, as well as the use of unqualified equipment for critical processes.

## Related Officers

- [Wenzheng Zhang](https://www.keypedia.com/people/wenzheng-zhang/44b1afce-5ba2-4013-82ac-52c6374c0be4)
- [Dogbeda F. Mackenzie](https://www.keypedia.com/people/dogbeda-f-mackenzie/c522e2cb-bf53-48f3-b88a-20b7aa0238d6)

Company: https://www.keypedia.com/companies/azzur-labs-san-diego-llc/9fe4a49d-3e5f-4a98-b46c-8dc7a1ef20af

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