# FDA 483 - BioZone Laboratories Inc. - January 26, 2016

Source: https://www.keypedia.com/records/483/biozone-laboratories-inc/28b5ff09-8298-42db-9062-9a39e4994df3

> FDA 483 for BioZone Laboratories Inc. on January 26, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioZone Laboratories Inc.
- Inspection Date: 2016-01-26
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: BioZone Laboratories Inc. in Pittsburg, CA, a drug contract manufacturer, was inspected from January 13-26, 2016. The inspection revealed significant deficiencies in laboratory controls, including lack of electronic record validation and audit trails, inadequate storage conditions for raw materials and drug products, and uncalibrated analytical equipment. Additionally, the firm failed to perform annual drug product reviews as per their own procedures.

## Related Officers

- [Anh M. Lac](https://www.keypedia.com/people/anh-m-lac/20a897c2-ad8c-4bea-8060-34ba80d64d1e)

Company: https://www.keypedia.com/companies/biozone-laboratories-inc/2704b3bd-facc-4903-a5d3-84d641925cab

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b