# FDA 483 - Biomat USA Inc - July 19, 2019

Source: https://www.keypedia.com/records/483/biomat-usa-inc/13a6aa87-6cbd-460a-94af-e5f63242d603

> FDA 483 for Biomat USA Inc on July 19, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA Inc
- Inspection Date: 2019-07-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: GCAM, Inc. in Pasco, WA, a plasmapheresis center, was inspected by the FDA. The inspection revealed a significant failure to obtain required donor contact information, specifically a postal address for 8-week post-donation contact. This indicates a lapse in donor eligibility screening procedures and standard operating procedures.

## Related Officers

- [Investigator at U.S.FDA](https://www.keypedia.com/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)

Company: https://www.keypedia.com/companies/biomat-usa-inc/e200a7b7-6d92-43fa-a0a1-05ec1daa0080

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