# FDA 483 - Blood Connection Inc (The) - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/blood-connection-inc-the/0f67a6f3-206e-4ee9-ab40-698dbaa2ff15

> FDA 483 for Blood Connection Inc (The) on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blood Connection Inc (The)
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: The Blood Connection, Incorporated in Wake Forest, NC, was cited for significant violations during an FDA inspection. The firm failed to defer donors who tested positive for Hepatitis B and did not notify these donors of their test results. Additionally, the company distributed biological products, including Apheresis Platelets and Red Blood Cells, in interstate commerce without the required biologics license.

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Company: https://www.globalkeysolutions.net/companies/blood-connection-inc-the/40ad0bf8-aea9-4ff3-92d2-98234f34afe3

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