Center for Assisted Reproduction (CARE

FDA inspection history in Bedford, Texas, 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 Bedford, Texas.

Cited most

Across all Center for Assisted Reproduction (CARE observations on file

  • 21 CFR 1271.55
    What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
    2
  • 21 CFR 1271.47
    What procedures must I establish and maintain?
    1
  • 21 CFR 1271.65
    How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?
    1

The complete Center for Assisted Reproduction (CARE 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
2025-09-10483 Form 483$99

Investigators on these documents

Elyshia Q. Danaher (1)

FEI number 3003926882 · most recent document Sep 10, 2025

About Center for Assisted Reproduction (CARE

How many FDA Form 483s has Center for Assisted Reproduction (CARE received?

FDA Intel has 1 Form 483 on file for Center for Assisted Reproduction (CARE; the most recent is dated Sep 10, 2025.

When was Center for Assisted Reproduction (CARE last inspected by FDA?

The most recent FDA inspection document on file for Center for Assisted Reproduction (CARE is a Form 483 dated Sep 10, 2025, for the site in Bedford, Texas.

What did FDA cite at Center for Assisted Reproduction (CARE?

The regulations cited most in the observations on file for Center for Assisted Reproduction (CARE are 21 CFR 1271.55 (What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?), 2 times; 21 CFR 1271.47 (What procedures must I establish and maintain?), 1 time; 21 CFR 1271.65 (How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?), 1 time.