# FDA 483 - Biomat USA Inc - Unknown Date

Source: https://www.keypedia.com/records/483/biomat-usa-inc/22ba4d8c-78d0-4f05-9c86-1254a931bc79

> 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: GCAM, Inc. in Indianapolis, IN, a source plasma establishment, was cited for significant deficiencies in its quality system and operational procedures during an FDA inspection. Observations included inadequate standard operating procedures for blood component processing and donor eligibility, exculpatory language in the informed consent, and failures in quality unit record review and adherence to donor reaction protocols. These issues indicate a lack of robust controls over critical aspects of plasma collection and donor safety.

## Related Officers

- [Kanako R. Ravenell, CSO](https://www.keypedia.com/people/kanako-r-ravenell-cso/0d0707d6-c799-4eda-b8c6-ed0f3bd909af)
- [Compliance Officer at FDA](https://www.keypedia.com/people/lauren-m-lilly/41582ad0-67b1-4c60-99e2-c1e3c63811c2)

Company: https://www.keypedia.com/companies/biomat-usa-inc/c0a53f56-8589-40af-9f9a-21ca16c1be1b

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