FDA Warning Letter to CareFusion 213, LLC (2026-04-30) — CGMP/Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated
TL;DR
In short: FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter to CareFusion 213, LLC on 2026-04-30 regarding CGMP/Finished Pharmaceuticals/Adulterated. The letter references 21 CFR 211.192. The verbatim letter is published on fda.gov.
Argus analysis
CareFusion 213, LLC received a Warning Letter from FDA's Center for Drug Evaluation and Research (CDER), dated 2026-04-30, regarding CGMP/Finished Pharmaceuticals/Adulterated. The letter follows an FDA inspection and is classified by Argus HQ as critical severity, consistent with Current Good Manufacturing Practice violations under 21 CFR Part 211 (drugs) or Part 600 (biologics).
The published letter cites 21 CFR 211.192. Warning Letters citing these sections generally concern Current Good Manufacturing Practice violations under 21 CFR Part 211 (drugs) or Part 600 (biologics), typically covering component testing, cleaning validation, laboratory controls, or investigation of out-of-specification results. The full citation language and supporting observations are in the verbatim letter linked below — Argus HQ does not add citations beyond what FDA published.
FDA Warning Letters carry a 15-business-day response window for the recipient to detail corrective actions. Peer compliance teams in the same product category typically use a letter like this one as an external audit trigger, checking whether their own quality system has documented coverage for the cited sections and whether their CAPA log would withstand the same line of inspection questioning.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
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 f…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- Is the FDA warning letter to CareFusion 213, LLC publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/carefusion-213-llc-722729-04302026.
- What does a "critical" severity rating mean for this letter?
- Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Warning Letter to CareFusion 213, LLC (2026-04-30) — CGMP/Finished Pharmaceuticals/Adulterated. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-carefusion-213-llc-2026-04-30-cgmp
"FDA Warning Letter to CareFusion 213, LLC (2026-04-30) — CGMP/Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-carefusion-213-llc-2026-04-30-cgmp.
Argus HQ Research. "FDA Warning Letter to CareFusion 213, LLC (2026-04-30) — CGMP/Finished Pharmaceuticals/Adulterated." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-carefusion-213-llc-2026-04-30-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_carefusion_213_llc_2026_04_30_cgmp_2026,
title = {FDA Warning Letter to CareFusion 213, LLC (2026-04-30) — CGMP/Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-carefusion-213-llc-2026-04-30-cgmp},
note = {Accessed: July 13, 2026}
}