Delta Kozmetik Gains FDA Corrective Action Closure After Dual Warning Letters Spanning Five Years

FDA's closure of two outstanding warning letters against Delta Kozmetik Sanayi Ve Ticaret signals that corrective action packages can satisfy agency scrutiny, but the closure language itself carries a compliance burden that QA directors at foreign-registered facilities should read carefully before treating this as a clean slate.

The Center for Drug Evaluation and Research (CDER) issued the closure letter on June 5, 2026, addressed to General Manager Gulten Erdemir at the firm's Tuzla, Istanbul site (FEI 3010166780). The letter formally acknowledges that violations cited in Warning Letter 320-21-51 (July 8, 2021) and Warning Letter 320-23-11 (February 13, 2023) appear to have been addressed. The five-year span between the first warning letter and this closure reflects the iterative nature of CDER's corrective action evaluation process for overseas manufacturers.

The operative word in the closure is "appears." FDA's language is deliberate: the agency states that future inspections and regulatory activities will further assess the adequacy and sustainability of the corrections. That framing places the evidentiary burden squarely on the manufacturer's ongoing documentation practices. For QA teams, this means CAPA records, process validation data, and quality system evidence must remain inspection-ready, not archived once the closure letter arrives.

The letter also reaffirms that closure does not preclude future regulatory action if violations are observed in subsequent inspections or through other means. Under 21 CFR Part 211, sustained compliance is not a point-in-time achievement; it is a continuous obligation. Foreign manufacturers seeking or maintaining U.S. market access should treat a warning letter closure as the beginning of a heightened surveillance period, not the end of a remediation cycle.

For regulatory affairs leads managing multi-site portfolios with FDA-registered overseas facilities, the Delta Kozmetik closure is a useful reference point: CDER will close warning letters when corrective actions are substantiated, but the post-closure monitoring posture remains active and the agency retains full enforcement discretion.

The next scheduled FDA inspection of the Tuzla facility will serve as the first measurable test of whether the corrections documented in the firm's corrective action response hold under direct agency scrutiny.

Source: FDA CDER via What's New: Drugs RSS Feed, June 9, 2026.