Warning Letter Record: Harbin Jixianglong Biotech Co., Ltd. (May 1, 2026) — CGMP/API/Adulterated and Misbranded Drugs

FDA Warning Letter — Violations FDA cited at Harbin Jixianglong Biotech Co., Ltd.

WARNING LETTER Harbin Jixianglong Biotech Co., Ltd. MARCS-CMS 723330 — May 01, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: 320-26-73 Product: Drugs Recipient: Recipient Name Mr. Guo Qing Leng Recipient Title President and General Manager Harbin Jixianglong Biotech Co., Ltd. North of Baoan Road, East of Changqing Street Hulan Qu Harbin Shi Heilongjiang Sheng , 150025 China Issuing Office: Center for Drug Evaluation and Research (CDER) United States Warning Letter 320-26-73 May 1, 2026 Dear Mr. Leng: The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Harbin Jixianglong Biotech Co., Ltd., FEI 3024038751, at North of Baoan Road, East of Changqing Street, Liminzhen Hulan District, Harbin, Heilongjiang, from November 3 to 7, 2025. This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). In addition, we reviewed your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS) and found that you failed to provide drug listing information for your relabeled semaglutide as required under section 510(j) of the FD&C Act, 21 U.S.C. 360(j), and 21 CFR Part 207. Furthermore, your relabeled semaglutide was manufactured in an establishment not duly registered with FDA. Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Under section 502(o) of the FD&C Act, 21 U.S.C. 352(o), a drug is misbranded if, among other things, it was manufactured in an establishment not duly registered under section 510, or if it was not included in a list required by section 510(j). Under section 301(a) of the FD&C Act, 21 U.S.C. 331(a), it is a prohibited act to introduce or deliver for introduction into interstate commerce any drug that is misbranded. These violations are described in more detail below. Your semaglutide API is also misbranded under sections 502(a) and 502(b)(1) of the FD&C Act, 21 U.S.C. 352(a) and 352(b)(1). We reviewed your November 26, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific deviations including, but not limited to, the following. 1. Failure of your quality unit to exercise its responsibility to ensure that APIs manufactured at your facility are in compliance with CGMP and failure to maintain complete traceability of APIs in commercial distribution. Your firm is a manufacturer of peptide APIs, including Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist APIs. FDA investigators observed that your firm lacked adequate quality unit (QU) oversight for the receipt of materials, repackaging, relabeling, and related controls for APIs. Specifically, there is no quality unit approved procedure governing the repackaging and relabeling operations for APIs sourced from external manufacturers prior to distribution to the U.S. market. For example: On (b)(4) , your firm purchased semaglutide API (batch (b)(4) ) from (b)(4) , a supplier that was not on your approved supplier list. You repackaged and relabeled this batch without documentation and created a new labeled batch number, CP-030-20250711. Furthermore, on the label of the container you identified your firm, “Harbin Jixianglong Biotech Co. Ltd.,” as the manufacturer of API rather than (b)(4) , the firm from which you purchased the API. You also changed the manufacturing date of the API from (b)(4) to July 25, 2025, and the retest dat