# FDA 483 - Golden West Biosolutions LLC - August 02, 2019

Source: https://www.keypedia.com/records/483/golden-west-biosolutions-llc/b68be361-4a37-4e82-a7b8-1c11ecd8e542

> FDA 483 for Golden West Biosolutions LLC on August 02, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Golden West Biosolutions LLC
- Inspection Date: 2019-08-02
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Golden West Biosolutions LLC, a blood establishment broker in Temecula, CA, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written standard operating procedures for processing and storage of human serum and plasma, as well as improper storage temperatures for recovered plasma. Additionally, the firm failed to include expiration dates on container labels for pooled source plasma.

## Related Officers

- [Elmina E Akwo](https://www.keypedia.com/people/elmina-e-akwo/ecd9066d-1647-4765-ad86-dbe5280241c5)

Company: https://www.keypedia.com/companies/golden-west-biosolutions-llc/590f50d4-d6b8-42b6-9ba8-c2e50ea030a5

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