Drug factory · FDA FEI 3002891260

Baxter Corporation

89 Centre St South, Alliston, Canada

Problems found, fixed voluntarily at FDA's last inspection, Jan 31, 2025.

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

2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Sodium Cation	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	0338-9834

Ended	Result	Program	Problems noted
Jan 31, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	4
Sep 17, 2019	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.

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies 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 components, drug product containers and closures at all times in a manner to prevent contamination.
Component identification test 21 CFR 211.84(d)(2)
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.

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 followed.
Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.

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