Central Coast Multispecialty Medical
Form 483 issued May 16, 2025 · Monterey, California
- Inspection
- May 13 – May 16, 2025
- Investigator
- Shelley H. Beausoleil
- Observations
- 2
- Pages
- 5
- FEI number
- 3003969216
In short: On May 16, 2025, FDA issued a Form 483 with 2 observations to Central Coast Multispecialty Medical in Monterey, California (FEI 3003969216) after an inspection that ran May 13 – May 16, 2025. The investigator was Shelley H. Beausoleil. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.75 (how do I screen a donor?).
At a glance
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.75(d) (1×) · 1271.75(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Donors were not determined to be ineligible that had risk factors or clinical evidence…
- 02
Donors were not screened by a review of relevant medical records for risk factors and clinical…
This inspection in context
Shelley H. Beausoleil
3 documents · 2025–2026
Cites 1271.75 (how do i screen a donor?) more than any other section. Most of their documents are for sites in California.
The firmCentral Coast Multispecialty Medical history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 1271.75(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Coast Multispecialty Medical?
FDA listed 2 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.75 (how do I screen a donor?). The opening words of each observation are shown on this page.
Who inspected Central Coast Multispecialty Medical?
Shelley H. Beausoleil is named on this Form 483, for the inspection of May 13 – May 16, 2025. Each investigator has a profile showing what they cite most.
When was Central Coast Multispecialty Medical inspected by FDA?
The inspection ran May 13 – May 16, 2025, and the Form 483 is dated May 16, 2025.
How do I get the full Form 483 for Central Coast Multispecialty Medical?
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.