Drug factory · FDA FEI 1019003

Baxter Healthcare Corporation

911 North Davis Avenue, Cleveland, MS, United States

Serious problems, FDA action at FDA's last inspection, Sep 29, 2025.

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

9 drug inspections on record since 2010: 4 with no problems, 2 with problems fixed voluntarily, 3 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Acetic Acid	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	0338-0656
Calcium Cation and Potassium Cation and Sodium Cation	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	0338-0104
Nitroglycerin	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	0338-1047, 0338-1049, 0338-1051
Sodium Cation	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	0338-0048
Sodium Chloride, Potassium Chloride, Magnesium Sulfate, Sodium Phosphate, and Po	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	0338-0190
Sodium Chloride, Sodium Lactate, Potassium Chloride and Calcium Chloride	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	0338-0114
Water	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	0338-0004

Ended	Result	Program	Problems noted
Sep 29, 2025	Serious problems, FDA action	Drug Quality Assurance	5
Nov 20, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	1
Mar 29, 2017	No problems found	Drug Quality Assurance	—
Mar 27, 2015	No problems found	Drug Quality Assurance	—
Jan 23, 2014	Serious problems, FDA action	Drug Quality Assurance	5
Mar 6, 2013	No problems found	Drug Quality Assurance	—
Jun 27, 2012	Serious problems, FDA action	Drug Quality Assurance	2
Oct 22, 2010	No problems found	Drug Quality Assurance	—
Feb 5, 2010	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.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that components, drug product containers, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing and packing of a drug product are not maintained in a good state of repair.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.

SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Approve or reject components, products 21 CFR 211.22(a)
The quality control unit lacks the responsibility and authority to reject all drug products.
Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the quality and purity of drug products.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration and inspection of electronic equipment is not performed according to a written program designed to assure proper performance.
Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Contract drug products--lack of responsibility 21 CFR 211.22(a)
The quality control unit lacks responsibility for approving or rejecting drug products manufactured under contract by another company.

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