Drug factory · FDA FEI 3002631703

Fresenius Kabi AB

Rapsgatan 7, Uppsala, Sweden

Problems found, fixed voluntarily at FDA's last inspection, Jan 24, 2025.

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

8 drug inspections on record since 2010: 1 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Thr	Makes it, makes the active ingredient and tests it	Fresenius Kabi, LLC	63323-712, 63323-714
Propofol	Makes it, makes the active ingredient and tests it	Fresenius Kabi USA, LLC, Fresenius Kabi, LLC	65219-800, 63323-269
Smoflipid	Makes it, makes the active ingredient and tests it	Fresenius Kabi, LLC	63323-820
Soybean Oil	Makes it, makes the active ingredient and tests it	Baxter Healthcare Corporation, Fresenius Kabi USA, LLC	0338-0518, 0338-0519, 0338-0520 +5
Vitamin A Palmitate, Ergocalciferol, .alpha.-Tocopherol, Dl-, Phytonadione	Makes it, makes the active ingredient and tests it	Fresenius Kabi USA, LLC	65219-335, 65219-337, 65219-339

Ended	Result	Program	Problems noted
Jan 24, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 21, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 15, 2020	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 16, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 7, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	1
Apr 11, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 25, 2012	No problems found	Drug Quality Assurance	—
Sep 30, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	5

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

Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures and laboratory control mechanisms are not followed and documented at the time of performance.

Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not reviewed and approved by the quality control unit.
Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not justified.
SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product.
Cleaning/maintenance records not kept 21 CFR 211.67(c)
Records are not kept for the inspection of equipment.

Registered with FDA for: analysis; api manufacture; manufacture.