Drug factory · FDA FEI 3003099089

Cardinal Health 414, LLC

5601 N. Powerline Road, Ste 108, Ft. Lauderdale, FL, United States

Problems found, fixed voluntarily at FDA's last inspection, Jul 31, 2025.

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

6 drug inspections on record since 2009: 1 with no problems, 5 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
Jul 31, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	5
Oct 26, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	5
Jun 17, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Mar 10, 2011	No problems found	Drug Quality Assurance	—
Mar 26, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 15, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

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

Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures.
Documentation of Non-Conforming Product Investigation 21 CFR 212.71(b)
You did not document the results of the investigation for a PET drug product that did not meet specifications.
Correction of problems 21 CFR 212.71(c)
You did not take action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.
Lack of disinfection, equipment/supplies from lower to higher quality air FDCA 501(a)(2)(A)
Lack of disinfection of supplies at each transition from areas of lower quality air to areas of higher quality air.
Personnel, blocked or disrupted first air FDCA 501(a)(2)(A)
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.

Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures.
Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is cleaned and properly installed, maintained, and capable of repeatedly producing valid results 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.
Conform to specs prior to release 21 CFR 212.70(c)
You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug product conforms to specifications before final release.
Documentation of Non-Conforming Product Investigation 21 CFR 212.71(b)
You did not document the results of the investigation for a PET drug product that did not meet specifications.
Correction of problems 21 CFR 212.71(c)
You did not take appropriate action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.

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