Drugs

Harbin Jixianglong Biotech API Deviations

An 11/3-11/7/2025 FDA inspection at the Harbin Jixianglong Biotech Co. active pharmaceutical ingredient (API) manufacturing facility in Harbin, Heilongjiang, China, found significant deviations from current good manufacturing practice (CGMP) regulations for APIs. A 5/1 Warning Letter says the four specific deviations were:

failure of the company quality unit to exercise its responsibility to ensure that APIs manufactured at the facility comply with CGMP, and failure to maintain complete traceability of APIs in commercial distribution;
failure to demonstrate that the firm’s manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes, and failure to adequately validate written procedures for the cleaning and maintenance of equipment;
failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that the firm’s APIs conform to established standards of quality and purity; and
failure to ensure that water used in the redacted manufacturing steps of a non-sterile API intended for a sterile drug product is monitored and controlled for total microbial counts, objectionable organisms, and endotoxins.

The letter also details drug listing violations and misbranded drugs. FDA recommends that the firm engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

The firm was placed on a 2/27 Import Alert, FDA says. Harbin was told to respond with a list of specific actions it has taken to correct the deviations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome