Cornerstone Medical Associates, Inc
Form 483 issued September 3, 2025 · Fresno, California
- Inspection
- Sep 2 – Sep 3, 2025
- Investigator
- Amy A. Johnson
- Observations
- 1
- Pages
- 2
- FEI number
- 3017424878
In short: On September 3, 2025, FDA issued a Form 483 with 1 observation to Cornerstone Medical Associates, Inc in Fresno, California (FEI 3017424878) after an inspection that ran Sep 2 – Sep 3, 2025. The investigator was Amy A. Johnson. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.260 (storage).
At a glance
1 of 1 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.260(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Storage temperatures of HCT/Ps were…
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 firmCornerstone Medical Associates, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.260(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cornerstone Medical Associates, Inc?
FDA listed 1 observation on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.260 (storage). The opening words of each observation are shown on this page.
Who inspected Cornerstone Medical Associates, Inc?
Amy A. Johnson is named on this Form 483, for the inspection of Sep 2 – Sep 3, 2025. Each investigator has a profile showing what they cite most.
When was Cornerstone Medical Associates, Inc inspected by FDA?
The inspection ran Sep 2 – Sep 3, 2025, and the Form 483 is dated September 3, 2025.
How do I get the full Form 483 for Cornerstone Medical Associates, Inc?
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.