Harbin Jixianglong Biotech Co., Ltd.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 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.

Passage 2

Failure to demonstrate that your 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.

Passage 3

You failed to appropriately validate your processes prior to release and distribution of your API. Specifically, you manufactured and distributed two batches of semaglutide API to the U.S. market despite having conducted no process validation.

Passage 4

Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that your APIs conform to established standards of quality and purity.

Passage 5

Failure to ensure that water used in the (b)(4) 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.