FDA Warning Letter Breakdown: Ineffective CAPA, 200+ Complaints, and a Corrective Action That Trending Data Flagged as Failing Three Quarters Before the Firm Acted
When a CAPA's effectiveness data shows the corrective action isn't working and the CAPA stays closed anyway, the quality system has a structural problem.
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On March 25, 2026, CDRH issued a warning letter to a large medical device manufacturer after an inspection conducted on December 1–12, 2025, at a division facility in New York that manufactures cardiovascular procedure kits, including angiographic control syringes and manifolds used for intra-arterial and intravenous administration of radiographic contrast media.
We thought this one deserves a close read because the central finding isn’t a typical missing procedure or an undocumented deviation, but a CAPA that the firm’s own verification-of-effectiveness (VOE) data showed was failing for three consecutive quarters. During that time, according to the warning letter, the firm didn’t route the CAPA back to a previous phase, didn’t open an additional CAPA earlier, and didn’t show the kind of risk/containment response its procedure contemplated when effectiveness checks failed.
The device products in question had a documented failure mode (disconnection from manifolds) that the firm’s own design FMEA identified as carrying “air embolism” as its highest-severity consequence.
The letter also gives an example of a cleanroom cleaning program that didn’t require cleaning the tops of manufacturing equipment, and a design verification exercise for ISO 80369-7 luer connector compliance that tested a single connector to represent a product family without a documented rationale.
Let’s break this one down.
Why this letter has lessons for device firms
Three threads in this letter are worth pulling on before getting into specifics.
The CAPA failure described here is one we see pretty often. And it’s the exact failure mode that every CAPA procedure is supposed to prevent: an ineffective corrective action that stays in place because the VOE feedback loop didn’t trigger reentry into the CAPA process. The firm’s SOP required routing back to a previous phase (or opening a new CAPA) when effectiveness checks failed. The trending data showed complaints-per-million exceeding the established threshold in Q1, Q2, and Q3 of 2025. The CAPA was not routed back or supplemented when Q1–Q3 2025 VOE data exceeded the threshold, and the firm did not acknowledge ineffectiveness and open CAPA-02612 until its January 13, 2026 response.
The severity calibration issue is important to call out. The firm’s Health Hazard Evaluation rated the risk “low,” but the design FMEA for the same failure mode identified air embolism as the highest-severity outcome. One of the 177 MDRs filed during the complaint window involved air injected into a patient. Another involved biohazard exposure to a clinician. A “low” HHE conclusion sitting alongside a dFMEA that flags the same failure as maximum-severity is the kind of internal inconsistency that tends to unravel the more attention FDA gives it.
The QMSR transition language at the end of the letter is worth noting given QMSR is live. The inspection occurred under the old QS regulation, but the FDA explicitly states that any corrective actions the firm proposes or implements must now be pursuant to QMSR requirements that took effect February 2, 2026. This is one of the first warning letters we’ve seen that formalizes this bridging expectation, and it’s a preview of how the agency plans to handle facilities inspected just before the QMSR effective date.
A CAPA that trending data flagged as ineffective for nine months
Let’s run through the sequence here:
The original CAPA (CAPA-01872 in this case) was opened in June 2023 after a spike in complaints about the subject syringes disconnecting from manifolds, which the firm attributed to excess silicone migrating to the luer connector. The corrective actions were limited: scrapping inventory and increasing the cleaning frequency of a piece of equipment. No design change or field action at that point.
Between opening the CAPA and the inspection, the firm received 221 complaints and filed 177 MDRs tied to this failure mode including one MDR involving air injected into a patient and one involving biohazard exposure to a clinician.
The VOE plan, set to start on January 15, 2025, established a threshold of 15.98 disconnection complaints per million (CPM). The actual CPM data for the product manufactured post-corrective action:
Q1 2025: 16.90 CPM
Q2 2025: 16.44 CPM
Q3 2025: 26.81 CPM
All three quarters exceeded the threshold. The total rate (including pre- and post-corrective-action product) was 39.95, 31.62, and 59.27 CPM for those same quarters.
The firm’s CAPA SOP required that when an effectiveness check fails, or additional root causes are identified, the CAPA “may be routed back to a previous phase or an additional CAPA may be opened,” and that “risk and containment activities must be considered when moving the CAPA to a previous phase.”
But according to the warning letter, none of that happened. The CAPA stayed closed, and no additional CAPA was opened or containment. The FDA noted this explicitly.
The HHE didn’t match the dFMEA
The June 2024 HHE (Qual-124366) concluded the risk was “low.” The design FMEA (RA2022047, Rev. 4) identified “air embolism” as the highest-severity issue for loose connections.
The FDA calls this inconsistency out directly in its letter. It’s the kind of finding that carries implications way beyond this one CAPA because an HHE that doesn’t reconcile with the design risk file undermines every downstream decision that depends on it (like field action scope, notification decisions, recall classification, and CAPA action commensurability).
In this case, the “low” HHE supported corrective actions that the FDA ultimately determined were not commensurate with the actual risk: inventory scrapping and increased cleaning, rather than design change or field action.
“Field notice” to removal, and an HHE that still doesn’t line up
The firm’s January 13, 2026, response acknowledged that the corrective action was ineffective, closed the original CAPA, opened a new one (CAPA-02612), and proposed a field correction with a safety notice rather than a full product removal. The rationale offered was effectiveness of prior communications, an upcoming alternative solution, and the prevention of market shortage.
By February 27, 2026, the firm had revised its plan to a removal, following discussions with the agency. An 806 report was submitted on March 13, 2026.
But the updated HHE (Qual-156459, approved February 26, 2026) still has problems the FDA flags:
The manufacturing quantities documented in the HHE fall short of the quantities the firm’s own Senior Director of Quality stated during the inspection had actually been manufactured.
The HHE doesn’t define the manufacturing start date of affected products.
The HHE specifies a corrective action start date of June 2024, while the warning letter indicates the corrective action began in mid-April 2024 under CAPA-01872.
No assurance was provided that the removal scope includes devices manufactured both before and after the (ineffective) corrective action.
For CAPA-02612 specifically, the letter says the firm didn’t commit to a timeline for the root cause investigation of the disconnections.
For CAPA-02627 (the systemic CAPA review opened to address the procedural failure), the firm didn’t identify actions that would make sure employees actually route CAPAs back to earlier phases when VOE data shows corrective actions are failing. That’s the procedural gap that allowed the original failure to happen, and it has not been closed.
A cleaning procedure didn’t cover the tops of the equipment
The second observation is narrower in scope but instructive, as we see it in various forms fairly frequently in our own audit and mock inspection work.
The firm’s manufacturing cleaning procedure required top-to-bottom cleaning of controlled environments and cleaning of “all equipment not routinely cleaned by operators.” The associated sign-off sheets listed vents, ceiling lights, walls, benches, cabinets, and fixtures, but didn’t include specific instructions to clean the tops of manufacturing equipment.
On December 1, 2025, the FDA investigator observed visible particulate accumulation on the tops of multiple pieces of manufacturing equipment in cleanrooms. The FDA notes approximately 114 complaints regarding foreign matter or hair in the package or device from December 2023 through at least December 1, 2025.
The firm’s response included ad-hoc cleaning, updated procedures, training, and a determination that validation of the cleaning process wasn’t required.
The FDA’s response is pointed here — pay attention! No corrective actions were identified to assess the impact on products in the field and in inventory manufactured in these cleanrooms since the last documented cleaning of equipment tops on November 26, 2023, nor to review the manufacturing dates of products associated with the 114 foreign-matter complaints as part of those complaint investigations.
This is a retrospective assessment gap. Even if the cleaning procedure is now adequate going forward, the population of products manufactured during the period when equipment tops weren’t being cleaned has not been evaluated, and the complaints associated with that population have not been reinvestigated in light of the new information.
Design verification that tested one connector to represent a family
The third observation is around design verification for ISO 80369-7 compliance across the polycarbonate female luer connector components of the fluid management product lines: stopcock, manifold, disposable transducer, Y adaptor, and so on.
The design verification protocol listed multiple connectors in its scope but tested only one.
The protocol contained no documented rationale for why testing a single connector was representative of the others.
The tested connector was not included in the final version of the design change analysis form that captured all affected connectors.
The firm’s response revised the design verification procedure, added template fields for part-selection rationale, and amended the design change file to include a justification.
The FDA’s assessment of the justification: the “unit rationale” provided fails to explain how design verification testing of the newly cited part covers anything beyond the manifold product family, and does not explain why that part number was not listed in the final design change analysis form that was supposed to capture all luer connectors affected by this design change.
The deficiency here is straightforward and still open in the letter: when a design verification tests a subset to represent a population, the rationale for representativeness has to be documented at the time, grounded in dimensional and functional equivalence, and reconcilable with the design change records.
A retrospective justification that doesn’t actually cover the families in scope doesn’t close the gap.
A few key takeaways
Some important things to consider in light of this letter that has import into similar operations:
The VOE feedback loop is (arguably) the most important control in a CAPA system, and it only works if the trigger is enforced! The firm had a threshold (15.98 CPM). It had data showing three consecutive quarters above that threshold. It had an SOP that said the CAPA “may be routed back” when effectiveness fails. The permissive language “may” rather than “shall” combined with no enforcement mechanism meant the feedback loop existed on paper but not in practice.