Curia New York Receives FDA Warning Letter Over Thousands of Undocumented Chromatographic Injections

Data integrity controls in Curia New York's API laboratory failed at a systemic level, according to an FDA warning letter issued September 18, 2026, following an inspection of the firm's Rensselaer, New York facility. The letter, addressed to CEO Philip Macnabb, documents thousands of unexplained chromatographic injections across Empower and TotalChrom software platforms over a 30-month window, a finding that carries direct adulteration implications under section 501(a)(2)(B) of the FD&C Act.

FDA investigators identified that laboratory analysts routinely performed HPLC and UPLC injections without adequate documentation or supervisory oversight, raising questions about whether product samples were being selectively tested outside the formal record. Analysts used the "Developer" role in Empower rather than the standard "Operator" role, bypassing audit-trail controls that would ordinarily link injections to a sample, product, or analytical rationale. In one documented instance on January 14, 2026, four trial injections on HPLC 49 could not be traced to any product or sample; the associated laboratory notebook 830-7 contained no reference to them. Over 70 trial injections were logged in TotalChrom in October 2025 alone.

For QA directors managing chromatographic data systems, the enforcement posture here is unambiguous: role-based access controls in 21 CFR Part 211-equivalent CGMP frameworks are not administrative formalities. When Developer-level access is used without documented justification, the audit trail's evidentiary value collapses. FDA's framing of the injections as potentially constituting unreported testing of product samples signals that investigators treated the pattern as a data integrity risk, not an isolated procedural lapse.

Curia submitted a response to the Form FDA 483 on February 27, 2026, attributing some injections to swab sample testing, but FDA found the explanation unsupported by contemporaneous notebook records. Subsequent correspondence was acknowledged but did not resolve the agency's concerns, resulting in formal warning letter escalation. FDA noted explicitly that the inspection findings are not an all-inclusive list of deviations, leaving open the possibility of broader systemic gaps at the Rensselaer site.

The agency warned that failure to adequately address the deviations may result in seizure or injunction without further notice, placing Curia's API manufacturing operations under measurable regulatory pressure as it works to remediate laboratory oversight controls and rebuild audit-trail integrity across its chromatography data systems.

Source: FDA Center for Drug Evaluation and Research (CDER) via FDA.gov Warning Letters, September 29, 2026. Inspection conducted January 28 to February 5, 2026; warning letter reference 320-26-127.