Chinese API Firm Warned for Testing Methods, Foreign Particles

November 1, 2019

API manufacturer Jiangsu NHWA Pharmaceutical drew a warning letter from the FDA for inadequate laboratory protocols and investigations into foreign particles in batches of active ingredients, following an inspection of its Jiawang site in Xuzhou.

The agency cited the stability protocols used to support expiration dates for its APIs. The protocols referenced methods in the 2015 Chinese Pharmacopeia, but it could not show that the tests were the same as or better than current U.S. Pharmacopeia methods.

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The agency found that “required tests for quality attributes in the USP were not part of the Chinese Pharmacopeia or [the firm’s] stability protocols.”