The U.S. Food and Drug Association (FDA) has issued a warning letter to Jiangsu NHWA.
The letter to the China-based drug manufacturing site has been cited regarding “significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).”
The location failed to ensure that all sampling plans and test procedures are scientifically sound and appropriate to ensure that the active pharmaceutical ingredients (API) conform to established standards of quality and purity. Additionally, forced degradation studies were not validated for their USP-grade (b)(4).
Jiangsu NHWA stated they would cease distribution until they have updated methods, conducted a comparison of test methods versus the current USP compendial methods, and tested reserve samples against the current USP standards.
The complete warning letter can be reviewed on the FDA website.