# FDA 483 - BioSurg, Inc. - April 19, 2019

Source: https://www.keypedia.com/records/483/biosurg-inc/ab64a560-3480-42a7-847f-9f74199d033e

> FDA 483 for BioSurg, Inc. on April 19, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioSurg, Inc.
- Inspection Date: 2019-04-19
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of BioSurg, Inc., a nonclinical laboratory in Winters, CA, from April 15-19, 2019, revealed several significant deficiencies. Findings included non-adherence to study protocols, failure to properly archive study specimens, and inadequate retention of reserve samples. Additionally, the firm failed to authorize and document deviations from standard operating procedures, specifically regarding out-of-range refrigerator temperatures for test articles.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/dustin-tran/52b41643-a5f9-4b2e-8da4-24beca42b1cd)
- [Supervisory Consumer Safety Officer](https://www.keypedia.com/people/joan-t-briones/f3b6554f-1a5c-4266-8a94-6c7488281659)

Company: https://www.keypedia.com/companies/biosurg-inc/0bfe74a2-27ae-4824-a178-b44649fe5ac3

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