Central California Blood Center
Form 483 issued August 29, 2025 · Fresno, California
- Inspection
- Aug 25 – Aug 29, 2025
- Investigator
- Amy A. Johnson
- Observations
- 3
- Pages
- 3
- FEI number
- 2970324
In short: On August 29, 2025, FDA issued a Form 483 with 3 observations to Central California Blood Center in Fresno, California (FEI 2970324) after an inspection that ran Aug 25 – Aug 29, 2025. The investigator was Amy A. Johnson. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
3 of 3 observations on this 483 concern biologics cgmp.
What FDA observed
Preview: the opening words of each observation- 01
The phlebotomy site is not prepared by a method that gives maximum assurance of a…
- 02
Failure to perform a thorough investigation and make a record of the conclusions and follow-up…
- 03
Written standard operating procedures including all steps to be followed in the collection and processing of…
This inspection in context
Amy A. Johnson
3 documents · 2019–2025
Cites 606.100(b) (standard operating procedures) more than any other section. Most of their documents are for sites in California.
The firmCentral California Blood Center history
The site's inspection history, in date order.
Similar 483sOther sites cited under 640.64(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central California Blood Center?
FDA listed 3 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected Central California Blood Center?
Amy A. Johnson is named on this Form 483, for the inspection of Aug 25 – Aug 29, 2025. Each investigator has a profile showing what they cite most.
When was Central California Blood Center inspected by FDA?
The inspection ran Aug 25 – Aug 29, 2025, and the Form 483 is dated August 29, 2025.
How do I get the full Form 483 for Central California Blood Center?
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.