April 30, 2026 FDA Warning Letter: CareFusion 213, LLC Cited for CGMP/Finished Pharmaceuticals/Adulterated

FDA Warning Letter — Violations FDA cited at CareFusion 213, LLC

WARNING LETTER CareFusion 213, LLC MARCS-CMS 722729 — April 30, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-72 Product: Drugs Recipient: Recipient Name Mr. Thomas E. Polen, Jr. Recipient Title Chairman, CEO and President CareFusion 213, LLC 1 Becton Drive Franklin Lakes , NJ 07417-1880 United States Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-72 April 30, 2026 Dear Mr. Polen: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, CareFusion 213, LLC (a wholly-owned subsidiary of Becton, Dickinson and Company (BD)), FEI 3004932373, at 1550 Northwestern Drive, El Paso, Texas, from October 15 to 24, 2025. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). We reviewed your November 17, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific violations including, but not limited to, the following. 1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your firm manufactures sterile drug products for (b)(4) , including (b)(4) , which are used (b)(4) . (b)(4) is also specifically labeled for use in (b)(4) . Your manufacturing process includes sterilizing the drug solution in sealed (b)(4) ampoules. Some (b)(4) undergo (b)(4) . Inadequate Complaint Investigations Since September 2023, your firm has received more than 2,500 customer complaints about your drug products including reports of foreign matter (e.g., (b)(4) particles and suspected mold), missing components, empty (b)(4) , and compromised package seals. Your investigations into these complaints were inadequate, as you repeatedly failed to conduct thorough investigations, adequately identify root causes, provide scientific rationale for your conclusions, and extend investigations to other potentially affected batches. As a result, your corrective actions and preventive actions (CAPAs) were ineffective. For example, your investigation into a complaint of black specks and possible mold on sterile (b)(4) was deficient. You concluded the most likely root cause was the unintentional introduction of particulate matter from the manufacturing environment, yet you failed to extend the investigation to other lots that were manufactured under the same conditions or on the same equipment. Additionally, your investigation did not sufficiently examine potential contributing factors such as facility and equipment cleaning and maintenance, and personnel practices. Your investigation concluded that “a project has been opened to further investigate the reported issue,” but you lacked evidence that the follow-up project was actually initiated. Furthermore, your investigation into a complaint identifying (b)(4) pieces, missing (b)(4) , and illegible printing on your (b)(4) was also inadequate. You indicated that the probable root cause of (b)(4) pieces and missing (b)(4) was equipment vibrations during manufacturing, but you did not extend the investigation to other batches processed on the same equipment. Your investigation also did not address the illegible printing on the (b)(4) identified in the complaint. FDA investigators observed numerous other examp