FDA Class I Recall Compliance and Reporting Support
Contract Overview
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AI Contract Overview
This contract focuses on providing regulatory compliance support specifically related to FDA-mandated recall activities. The scope includes managing recall reporting, documentation, and status updates to ensure adherence to 21 CFR Part 7 requirements, which govern the procedures for mandatory recalls of FDA-regulated products. The efforts are targeted toward Class I recalls, which typically involve situations where there is a reasonable probability that the use of or exposure to a violative product may cause serious adverse health consequences or death. The subcontract, titled "FDA Class I Recall Compliance and Reporting Support," was posted on June 5, 2026, and falls under the NAICS code 541611, which pertains to Administrative Management and General Management Consulting Services. It is administered by the Department of Veterans Affairs through the 257-NETWORK Contract Office 17. The place of performance is located in Dallas, and the contract duties revolve around supporting the agency’s compliance with federal recall regulations by ensuring timely and accurate recall activities are documented and communicated effectively.
General Info
Agency
NAICS
Place of Performance
Dallas, TX, USASet-Aside
Documents
This scope was carved out of 36C25726F0091.
The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.
RECALL Contour PLUS Blood Glucose Test Strips
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