Drug factory · FDA FEI 3008619510

Cardinal Health 414, LLC

4540 E. Cotton Gin Loop, Phoenix, AZ, United States

Problems found, fixed voluntarily at FDA's last inspection, Jan 23, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

5 drug inspections on record since 2011: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Flurpiridaz F-18	Makes it	GE Healthcare Inc.	0407-8787
Flutemetamol F-18	Makes it	Medi-Physics Inc. dba GE Healthcare.	17156-067

Ended	Result	Program	Problems noted
Jan 23, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	2
Mar 16, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	1
Oct 16, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	4
May 1, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 13, 2011	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.
Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is cleaned and suitable for its intended purposes that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained.

Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.

Examine, approve or reject 21 CFR 212.20(b)
You did not approve or reject components in a manner that ensures compliance with procedures and specifications affecting the identity, strength, quality or purity of a PET drug.
Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.
Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
Sub-batches 21 CFR 212.70(c)
You did not conduct an appropriate laboratory determination on a PET drug produced in sub-batches before final release to ensure that each sub-batch conformed to specifications.

Registered with FDA for: manufacture; positron emission tomography drug production.