California Fertility Partners, A Medical Group, Professional Corporations

Form 483 issued December 3, 2024

Inspection
Nov 20 – Dec 3, 2024
Observations
1
Pages
3
FEI number
3003942615

In short: On December 3, 2024, FDA issued a Form 483 with 1 observation to California Fertility Partners, A Medical Group, Professional Corporations (FEI 3003942615) after an inspection that ran Nov 20 – Dec 3, 2024. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.75 (how do I screen a donor?).

At a glance

1 of 1 observations on this 483 concern hct/p.

HCT/P1

Most cited: 21 CFR 1271.75(a)(1) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    Donors were not screened by a review of relevant medical records for risk factors and clinical…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at California Fertility Partners, A Medical Group, Professional Corporations?

FDA listed 1 observation 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.

When was California Fertility Partners, A Medical Group, Professional Corporations inspected by FDA?

The inspection ran Nov 20 – Dec 3, 2024, and the Form 483 is dated December 3, 2024.

How do I get the full Form 483 for California Fertility Partners, A Medical Group, Professional Corporations?

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.

$99Get it free