Drug factory · FDA FEI 2649614

Baxter Healthcare Corporation

Rd. 721 Km. 0.3, Aibonito, PR, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 23, 2026.

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 2018: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Anhydrous Dextrose	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	0338-0017, 0338-0170, 0338-0172 +9
Potassium Cation	Tests it	Baxter Healthcare Corporation	0338-0703, 0338-0705, 0338-0709
Sodium Cation	Makes it, tests it, packages it, labels it and sterilizes it	Baxter Healthcare Corporation	0338-0049, 0338-0160, 0338-0162 +9

Ended	Result	Program	Problems noted
Sep 23, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	5
Nov 29, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	1
Nov 15, 2023	No problems found	Drug Quality Assurance	—
Aug 17, 2018	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.

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.
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 written.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.

Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
Complaint records are deficient in that they do not include the findings of the investigation and follow-up.

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