# FDA 483 - Biomat USA Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/biomat-usa-inc/9d937614-c310-41f9-a65a-058e7f72c4a0

> FDA 483 for Biomat USA Inc on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA Inc
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: BioTek America, LLC, a plasmapheresis center in Louisville, Kentucky, was inspected by the FDA from February 28 to March 2, 2023. The inspection revealed that the firm failed to include all required information in the notification and counseling messages provided to donors deferred due to reactive test results for transfusion-transmitted diseases. This deficiency impacts the clarity of deferral status and the completeness of test results provided to affected donors.

## Related Officers

- [Barbara G. Peoples](https://www.globalkeysolutions.net/people/barbara-g-peoples/43dd2619-3f3b-4bb2-b4ad-c522f3c31225)

Company: https://www.globalkeysolutions.net/companies/biomat-usa-inc/9acb2c08-de6c-4e5c-99dc-70cb63452c9d

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd