Global Premier Fertility Orange County LLC

FDA inspection history in Newport Beach, California, 2025

1
Form 483

Every document, by year

  • Form 483

2025: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2025One Form 483, at Newport Beach, California.

Cited most

Across all Global Premier Fertility Orange County observations on file

  • 21 CFR 1271.55(b)(1)
    What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
    3

The complete Global Premier Fertility Orange County file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2025-04-11483 Form 483$99

Investigators on these documents

Melsomar R. Ramos (1)

FEI number 3018118424 · most recent document Apr 11, 2025

About Global Premier Fertility Orange County LLC

How many FDA Form 483s has Global Premier Fertility Orange County LLC received?

FDA Intel has 1 Form 483 on file for Global Premier Fertility Orange County LLC; the most recent is dated Apr 11, 2025.

When was Global Premier Fertility Orange County LLC last inspected by FDA?

The most recent FDA inspection document on file for Global Premier Fertility Orange County LLC is a Form 483 dated Apr 11, 2025, for the site in Newport Beach, California.

What did FDA cite at Global Premier Fertility Orange County LLC?

The regulations cited most in the observations on file for Global Premier Fertility Orange County LLC are 21 CFR 1271.55(b)(1) (What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?), 3 times.