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FDA Warning Letter · #723330

Harbin Jixianglong Biotech Co., Ltd. — FDA Warning Letter (May 1, 2026)

Issued May 1, 2026Status: activeCenter for Drug Evaluation and Research (CDER)

Primary Source

View the original FDA letter on fda.gov →

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026

Summary

Company
Harbin Jixianglong Biotech Co., Ltd.
Letter number
#723330
Issue date
May 1, 2026
Subject
CGMP/API/Adulterated and Misbranded Drugs

What FDA cited

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.

From the letter

Read full letter on FDA.gov →

Quoted verbatim from the FDA warning letter dated May 1, 2026

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.

Source: U.S. Food and Drug Administration. Quoted as a verbatim excerpt for editorial commentary; no claim is made beyond what FDA itself has published. The full letter is available at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/harbin-jixianglong-biotech-co-ltd-723330-05012026

What FDA warning letters mean

A warning letter is FDA's principal means of telling a company that the agency considers something it's doing — a marketing claim, a manufacturing practice, a labeling choice — to violate the Federal Food, Drug, and Cosmetic Act. Companies typically have 15 working days to respond.

A warning letter is not a recall, a criminal charge, or a finding that the company has broken the law. It is the start of a regulatory conversation. FDA may issue a close-out letter once it is satisfied that the company has corrected the cited issues.

For compounded GLP-1 telehealth providers, the most common citations involve unapproved new drug claims, misbranding, and the use of bulk drug substances not on FDA's approved list under FDCA sections 503A and 503B.

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