B Positive National Blood Services -
Form 483 issued February 2, 2026 · Wyoming, Pennsylvania
- Inspection
- Jan 28 – Feb 2, 2026
- Investigator
- Michele Gottshall
- Observations
- 3
- Pages
- 3
- FEI number
- 3023715801
In short: On February 2, 2026, FDA issued a Form 483 with 3 observations to B Positive National Blood Services - in Wyoming, Pennsylvania (FEI 3023715801) after an inspection that ran Jan 28 – Feb 2, 2026. The investigator was Michele Gottshall. Most observations concern biologics CGMP.
At a glance
3 of 3 observations on this 483 concern biologics cgmp.
What FDA observed
Preview: the opening words of each observation- 01
Records are not made concurrently with the performance of each step in…
- 02
Written standard operating procedures including all steps to be followed in the collection, processing, storage and…
- 03
Failure to use supplies and reagents in a maimer consistent with instructions…
This inspection in context
Michele Gottshall
12 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmB Positive National Blood Services - history
The site's inspection history, in date order.
Similar 483sOther sites cited under 600.12(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at B Positive National Blood Services -?
FDA listed 3 observations on this Form 483, mostly about biologics CGMP. The opening words of each observation are shown on this page.
Who inspected B Positive National Blood Services -?
Michele Gottshall is named on this Form 483, for the inspection of Jan 28 – Feb 2, 2026. Each investigator has a profile showing what they cite most.
When was B Positive National Blood Services - inspected by FDA?
The inspection ran Jan 28 – Feb 2, 2026, and the Form 483 is dated February 2, 2026.
How do I get the full Form 483 for B Positive National Blood Services -?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.