California Fertility Clinics LLC
Form 483 issued June 12, 2025
- Inspection
- Jun 9 – Jun 12, 2025
- Investigator
- Creighton T. Tuzon
- Observations
- 2
- Pages
- 3
- FEI number
- 3005405914
In short: On June 12, 2025, FDA issued a Form 483 with 2 observations to California Fertility Clinics LLC (FEI 3005405914) after an inspection that ran Jun 9 – Jun 12, 2025. The investigator was Creighton T. Tuzon. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.47 (what procedures must I establish and maintain?).
At a glance
2 of 2 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.47 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures were not designed to ensure compliance with…
- 02
A standard operating procedure for the release of HCT/Ps from donors that test reactive for cytomegalovirus…
This inspection in context
Creighton T. Tuzon
6 documents · 2020–2025
Cites 1271.47 (what procedures must i establish and maintain?) more than any other section. Most of their documents are for sites in California.
The firmCalifornia Fertility Clinics LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.47
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at California Fertility Clinics LLC?
FDA listed 2 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.47 (what procedures must I establish and maintain?). The opening words of each observation are shown on this page.
Who inspected California Fertility Clinics LLC?
Creighton T. Tuzon is named on this Form 483, for the inspection of Jun 9 – Jun 12, 2025. Each investigator has a profile showing what they cite most.
When was California Fertility Clinics LLC inspected by FDA?
The inspection ran Jun 9 – Jun 12, 2025, and the Form 483 is dated June 12, 2025.
How do I get the full Form 483 for California Fertility Clinics LLC?
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.