# FDA 483 - Biotek America, LLC/dba Freedom Plasma - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/biotek-america-llcdba-freedom-plasma/f8b3cbe7-e0eb-4ac2-a339-e161de7cd6be

> FDA 483 for Biotek America, LLC/dba Freedom Plasma on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biotek America, LLC/dba Freedom Plasma
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Biotek America, LLC/dba Freedom Plasma in Paducah, Kentucky, received a Form 483 with two observations following an inspection of its plasmapheresis center. The firm was cited for requiring donors to sign an arbitration agreement containing exculpatory language that waives legal rights, and for implementing a major change to its informed consent process via video without prior FDA approval, which also failed to adequately explain risks to donors.

## Related Officers

- [Michelle D. Gutierrez](https://www.globalkeysolutions.net/people/michelle-d-gutierrez/b6117afc-1a01-41b0-a0e6-6aeb33935968)

Company: https://www.globalkeysolutions.net/companies/biotek-america-llcdba-freedom-plasma/d6fc7942-d067-4e9b-8984-2b03116e995c

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