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FDA establishment 3004932373, El Paso, Texas, United States. Part of CareFusion 213's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 8
Official action indicated: 2
Last inspection ended: Oct 24, 2025
Warning letters: 1
Recalls since 2016: 14
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
21 CFR 211.160(a). Following/documenting laboratory controls Established test procedures are not documented at the time of performance.
21 CFR 211.188(b). Batch production and Batch Control Record Requirements The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.68(b). input/output verification Input to and output from the computer are not checked for accuracy.
Official Action Indicated (OAI)
Sep 29, 2023
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
5 cited references
21 CFR 211.84(d)(2). Component written specification Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
21 CFR 211.84(b). Representative Samples Representative samples are not taken of each shipment of each lot of components for testing or examination.
Voluntary Action Indicated (VAI)
Dec 15, 2016
Devices · Compliance: DevicesDrugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Mar 11, 2014
Devices · Compliance: Devices
None posted
No Action Indicated (NAI)
Feb 8, 2013
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jun 3, 2011
Drugs · Drug Quality Assurance
4 cited references
21 CFR 314.81(b)(1)(ii). Failure to meet specifications An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
21 CFR 211.188(b)(5). In-process and laboratory control results Batch production and control records do not include in-process results for each batch of drug product produced.
21 CFR 211.94(a). Reactive/Additive/Absorptive Containers/Closures Drug product containers or closures are reactive so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.
21 CFR 211.110(a). Written in-process control procedures Written procedures are not established and followed that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch.
Official Action Indicated (OAI)
Jan 27, 2011
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.142(a). Quarantine - actual practice Drug products are not quarantined before being released by the quality control unit.
21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Voluntary Action Indicated (VAI)
Dec 16, 2009
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Warning Letters
Letters naming this establishment; each opens the letter
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. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. 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, warning letters and enforcement reports
El Paso, Texas, United States. Part of