# FDA 483 - PlasmaLab International, Inc. - August 15, 2019

Source: https://www.keypedia.com/records/483/plasmalab-international-inc/2ad89af0-693e-4bb0-a852-9a7f742f754b

> FDA 483 for PlasmaLab International, Inc. on August 15, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PlasmaLab International, Inc.
- Inspection Date: 2019-08-15
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of PlasmaLab International, Inc. in Everett, WA, revealed a significant lapse in their quality system regarding donor adverse reactions. The firm failed to prepare and maintain written reports of investigations into adverse reactions, specifically regarding hematomas experienced by multiple donors. This indicates a deficiency in their donor reaction management procedures.

## Related Documents

- [483 - 2019-08-15](https://www.keypedia.com/records/483/plasmalab-international-inc/a52365f6-928d-481d-a3bf-c329a4d56a9b)
- [483 - 2019-08-15](https://www.keypedia.com/records/483/plasmalab-international-inc/824436e7-a95c-4f3e-b03d-4ea47e592fa0)

## Related Officers

- [Investigator](https://www.keypedia.com/people/peter-s-kessler/f3a9dea7-3a2d-4c86-9ec6-97791f9b6c21)

Company: https://www.keypedia.com/companies/plasmalab-international-inc/3c83faf4-6827-4224-8d97-4fd4fd9a8cc8

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822