Drug factory · FDA FEI 1028892

Liebel-Flarsheim Company LLC

8800 Durant Road, Raleigh, NC, United States

Serious problems, FDA action at FDA's last inspection, Apr 8, 2025.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

7 drug inspections on record since 2010: 5 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Diatrizoic Acid	Makes it and tests it	Liebel-Flarsheim Company LLC	0019-4816
Gadolinium Cation (3+)	Makes it, packages it and labels it	Guerbet LLC	67684-2001, 67684-3001
Gadopiclenol	Makes it, packages it and labels it	Bracco Diagnostics Inc., Guerbet LLC	0270-7015, 0270-7020, 0270-7025 +11
Iothalamic Acid	Makes it and tests it	Liebel-Flarsheim Company LLC	0019-0862
Ioversol	Makes it and tests it	Liebel-Flarsheim Company LLC	0019-1323, 0019-1332, 0019-1333
Sodium Cation	Makes it and tests it	Liebel-Flarsheim Company LLC	0019-1188

Ended	Result	Program	Problems noted
Apr 8, 2025	Serious problems, FDA action	Drug Quality Assurance	5
Aug 31, 2018	No problems found	Drug Quality Assurance	—
Jul 29, 2016	No problems found	Drug Quality Assurance	—
Jul 25, 2014	No problems found	Drug Quality Assurance	—
May 4, 2012	No problems found	Drug Quality Assurance	—
Aug 20, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	3
Mar 5, 2010	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.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and standards designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
Floors, walls, ceiling surfaces 21 CFR 211.42(c)(10)(i)
Aseptic processing areas are deficient in that floors are not smooth and/or hard surfaces that are easily cleanable.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
There was a failure to handle and store closures at all times in a manner to prevent contamination.

Registered with FDA for: analysis; label; manufacture; pack.