Drug factory · FDA FEI 1717928

Cardinal Health 418, Inc.

16401 East 33rd Drive Suite 60, Aurora, CO, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 21, 2020.

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

3 drug inspections on record since 2014: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

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

Ended	Result	Program	Problems noted
Feb 21, 2020	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jul 11, 2018	No problems found	Drug Quality Assurance	—
Jun 17, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	2

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

Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
input/output verification 21 CFR 211.68(b)
Input to and output from the computer and related systems of formulas are not checked for accuracy.

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