Warning Letter — Erkul Kozmetik Sanayi ve Ticaret A.S.
The FDA issued a warning letter to Erkul Kozmetik Sanayi ve Ticaret A.S. following an evaluation by the Center for Drug Evaluation and Research (CDER).
This notice affects Erkul Kozmetik Sanayi ve Ticaret A.S., specifically their manufacturing and quality departments, and potentially other international cosmetic manufacturers producing products that fall under FDA drug regulations.
This enforcement action indicates that the FDA is actively monitoring international manufacturers whose products may be classified as drugs or fail to meet CGMP requirements. Regulatory professionals should interpret this as a signal that the agency is maintaining oversight of the boundary between cosmetics and drug products, particularly for firms operating outside the United States. The issuance by CDER suggests the products in question likely fall under drug regulatory frameworks rather than purely cosmetic ones.
Quality units should review the regulatory status of all cosmetic products to ensure they do not meet the definition of a drug under FDA regulations. Manufacturing facilities producing products intended for the U.S. market must ensure full compliance with Current Good Manufacturing Practice (CGMP) standards to avoid enforcement actions such as warning letters or import bans.
FDA Warning Letter issued to: Erkul Kozmetik Sanayi ve Ticaret A.S.. 06/02/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/erkul-kozmetik-sanayi-ve-ticaret-721964-06022026
Open in openFDA / FDA.gov