FDA Cites Harbin Jixianglong Biotech Co., Ltd. in 2026-05-01 Warning Letter — CGMP/API/Adulterated and Misbranded Drugs
Letter issued · posted to fda.gov .
Subject as published: CGMP/API/Adulterated and Misbranded Drugs
TL;DR
Here's the summary: FDA issued a Warning Letter to Harbin Jixianglong Biotech Co., Ltd. on 2026-05-01 citing: CGMP/API/Adulterated and Misbranded Drugs. Full letter: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026
Argus analysis
Harbin Jixianglong Biotech Co., Ltd. (MARCS-CMS 723330, FEI 3024038751) received an FDA Warning Letter dated May 1, 2026 from the Center for Drug Evaluation and Research (CDER). The letter cites: CGMP/API/Adulterated and Misbranded Drugs. FDA posts Warning Letters to fda.gov after an internal review period; this one was made public on May 19, 2026.
CGMP citations typically reference 21 CFR Part 211 (finished pharmaceuticals) or Part 111 (dietary supplements), covering subjects such as identity testing of incoming components, validated cleaning procedures, batch-failure investigations, and stability program design. Repeat or systemic findings are what typically drive FDA toward import alert or consent decree escalation.
FDA Warning Letters typically specify a 15-working-day response window for the recipient to detail corrective actions. Compliance teams at peer companies in the same CGMP (Current Good Manufacturing Practice) category commonly use a newly published letter as a prompt to re-check their own procedures against the same citation, and to watch fda.gov for a close-out letter confirming the cited firm's corrective action was accepted — or, absent one, for escalation to import alert, injunction, or product seizure.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
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…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What is the regulatory background for a CGMP — Current Good Manufacturing Practice warning letter?
- CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Harbin Jixianglong Biotech Co., Ltd. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Harbin Jixianglong Biotech Co., Ltd. as of 2026-05-19. Argus ingests new FDA enforcement records daily.
- What FDA violations was Harbin Jixianglong Biotech Co., Ltd. cited for?
- The FDA Warning Letter to Harbin Jixianglong Biotech Co., Ltd. (issuing office: Center for Drug Evaluation and Research (CDER)) cites: CGMP/API/Adulterated and Misbranded Drugs. Classification: CGMP — Current Good Manufacturing Practice.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Cites Harbin Jixianglong Biotech Co., Ltd. in 2026-05-01 Warning Letter — CGMP/API/Adulterated and Misbranded Drugs. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-harbin-jixianglong-biotech-co-ltd-2026-05-01-cgmp
"FDA Cites Harbin Jixianglong Biotech Co., Ltd. in 2026-05-01 Warning Letter — CGMP/API/Adulterated and Misbranded Drugs." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-harbin-jixianglong-biotech-co-ltd-2026-05-01-cgmp.
Argus HQ Research. "FDA Cites Harbin Jixianglong Biotech Co., Ltd. in 2026-05-01 Warning Letter — CGMP/API/Adulterated and Misbranded Drugs." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-harbin-jixianglong-biotech-co-ltd-2026-05-01-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_harbin_jixianglong_biotech_co_ltd_2026_05_01_cgmp_2026,
title = {FDA Cites Harbin Jixianglong Biotech Co., Ltd. in 2026-05-01 Warning Letter — CGMP/API/Adulterated and Misbranded Drugs},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-harbin-jixianglong-biotech-co-ltd-2026-05-01-cgmp},
note = {Accessed: July 13, 2026}
}