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B Positive National Blood Services - Wyoming, LLC.
FDA establishment 3023715801, Wyoming, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Feb 2, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection, processing, storage and distribution of blood and blood components for further manufacturing purposes were not always established.
21 CFR 606.65(e). Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.
21 CFR 600.12(a). Maintenance - concurrence Records are not made concurrently with the performance of each step in the distribution of products.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Wyoming, Pennsylvania, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.