B Positive National Blood Services - Wilkes Barre, LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection VAI · Oct 29, 2025
  • No warning letters matched by name
Inspections 1 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

B Positive National Blood Services - Wilkes Barre, LLC has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "B Positive National Blood Services - Wilkes Barre, LLC" is on file.

What these totals cover: FDA records filed under the name "B Positive National Blood Services - Wilkes Barre, LLC" and its spelling variant "B Positive National Blood Services - Wilkes Barre".

Latest inspection
Oct 29, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections1Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

1 inspection on Oct 29, 2025.

DateSiteProductClassificationFEI
Oct 29, 2025Edwardsville, PABiologicsVoluntary Action Indicated (VAI)3023718437
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3023718437Edwardsville, PA1Oct 29, 2025

B Positive National Blood Services - Wilkes Barre, LLC and the FDA: common questions

Has B Positive National Blood Services - Wilkes Barre, LLC received an FDA warning letter?

No FDA warning letter addressed to the name "B Positive National Blood Services - Wilkes Barre, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has B Positive National Blood Services - Wilkes Barre, LLC received an FDA Form 483?

FDA has not published a Form 483 for "B Positive National Blood Services - Wilkes Barre, LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect B Positive National Blood Services - Wilkes Barre, LLC?

The most recent FDA inspection on file ended Oct 29, 2025 at Edwardsville, PA and was classified VAI. FDA has 1 inspection of B Positive National Blood Services - Wilkes Barre, LLC on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.