Warning Letter — Harbin Jixianglong Biotech Co., Ltd.
The FDA issued a Warning Letter to Harbin Jixianglong Biotech Co., Ltd. through the Center for Drug Evaluation and Research (CDER) following a review of compliance standards.
This notice directly affects Harbin Jixianglong Biotech Co., Ltd. and may impact downstream partners or distributors relying on their drug products or ingredients.
The issuance of a Warning Letter by CDER indicates significant deviations from current good manufacturing practice (cGMP) at the facility level. This suggests that products manufactured by the firm may be considered adulterated under the Federal Food, Drug, and Cosmetic Act, potentially leading to import alerts or supply chain disruptions for commercial partners.
QA and Regulatory teams should conduct an immediate review of manufacturing compliance for drug products or ingredients sourced from this facility. Management must ensure that all quality systems and production controls meet current good manufacturing practice (cGMP) standards for items intended for the US market.
FDA Warning Letter issued to: Harbin Jixianglong Biotech Co., Ltd.. 05/01/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026
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