Drug factory · FDA FEI 3002851530

Fresenius Kabi Deutschland GmbH

Freseniusstr. 1 Pfingstweide 53, Friedberg, Germany

Problems found, fixed voluntarily at FDA's last inspection, Dec 21, 2023.

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

4 drug inspections on record since 2014: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Anhydrous Dextrose	Makes it, makes the active ingredient and tests it	Becton Dickinson and Company, Fresenius Kabi USA, LLC, Fresenius Kabi, LLC	17271-720, 17271-721, 65219-238 +3
Anhydrous Dextrose and Sodium Cation	Makes it, makes the active ingredient and tests it	Fresenius Kabi, LLC	63323-867, 63323-869, 63323-870 +2
Balanced Salt Solution	Makes it and tests it	Fresenius Kabi USA, LLC	65219-258
Calcium Cation and Potassium Cation and Sodium Cation	Makes it, makes the active ingredient and tests it	Becton Dickinson and Company	17271-710
Sodium Cation	Makes it, makes the active ingredient and tests it	Becton Dickinson and Company, Fresenius Kabi USA, LLC, Fresenius Kabi, LLC	17271-700, 17271-701, 17271-703 +14
Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride and Magnes	Makes it, makes the active ingredient and tests it	Fresenius Kabi USA, LLC	65219-387, 65219-389
Water	Makes it, makes the active ingredient and tests it	Becton Dickinson and Company, Fresenius Kabi USA, LLC, Fresenius Kabi, LLC	17271-750, 17271-802, 65219-495 +3

Ended	Result	Program	Problems noted
Dec 21, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Oct 19, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 11, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 26, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	7

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

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 written.
Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
Product flow through building is inadequate 21 CFR 211.42(b)
The flow of drug product containers and closures though the building is not designed to prevent contamination.
Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over air pressure, micro-organisms, and dust is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine checking of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.
Representative Samples 21 CFR 211.84(b)
Representative samples are not taken of each shipment of each lot of drug product containers and closures for testing or examination.

Registered with FDA for: analysis; manufacture.