# FDA 483 - Forest Ambulatory Surgical Associates LLC - March 02, 2020

Source: https://www.keypedia.com/records/483/forest-ambulatory-surgical-associates-llc/55f30b86-a86e-4070-bed9-b9fad84db6f1

> FDA 483 for Forest Ambulatory Surgical Associates LLC on March 02, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Forest Ambulatory Surgical Associates LLC
- Inspection Date: 2020-03-02
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Forest Ambulatory Surgical Associates, LLC in San Jose, CA, a human tissue establishment, revealed significant deficiencies in their handling and storage of Human Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps). Observations included failures to document transfer temperatures, maintain appropriate shipping conditions with expired materials, perform routine equipment calibration, and conduct periodic reviews of recorded temperatures.

## Related Officers

- [investigator](https://www.keypedia.com/people/seyyida-saterfield/6e7569f6-4f95-40d1-9707-6a6c530bfe13)

Company: https://www.keypedia.com/companies/forest-ambulatory-surgical-associates-llc/6a5f3dc4-5393-4c31-b61f-a865ba83c6be

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