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FDA establishment 2649614, Aibonito, Puerto Rico, United States. Part of Baxter Healthcare's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 8
Official action indicated: 1
Last inspection ended: Sep 23, 2026
Warning letters: 0
Import refusals since 2024: 4
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
21 CFR 211.110(a). Control procedures to monitor and validate performance 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.
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and written.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
Voluntary Action Indicated (VAI)
Nov 29, 2023
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
Voluntary Action Indicated (VAI)
Nov 15, 2023
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Aug 17, 2018
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jun 8, 2015
Devices · Compliance: Devices
1 cited reference
21 CFR 820.250(b). Sampling plans Sampling plans are not based on valid statistical rationale.
Voluntary Action Indicated (VAI)
May 12, 2014
Devices · Compliance: Devices
None posted
Official Action Indicated (OAI)
Sep 26, 2013
Devices · Compliance: Devices
4 cited references
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been adequately established.
21 CFR 806.10(a)(2). Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
21 CFR 820.86. Acceptance status The acceptance status of product was not identified to indicate conformance or nonconformance with acceptance criteria and maintained.
Voluntary Action Indicated (VAI)
May 20, 2011
Devices · Compliance: Devices
None posted
Voluntary Action Indicated (VAI)
Import Refusals
4 refused shipment lines since 2024, grouped by product and charges
Product
Charges
Latest
SET, ADMINISTRATION, INTRAVASCULARDevices · 80FPA
Maker not registered with FDADrug or device not listed with FDA
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Aibonito, Puerto Rico, United States. Part of