Jiangsu NHWA
FDA’s warning letter to Jiangsu comes after a five-day inspection of the company’s Jiawang facility last April that uncovered issues with the company’s product testing procedures and investigations into out-of-specification (OOS) test results for active pharmaceutical ingredients (APIs) distributed to the US.
According to FDA, Jiangsu NHWA followed stability testing protocols from the 2015 Chinese Pharmacopoeia for one of its APIs and was “not able to demonstrate that the tests used are equivalent to or better than the current [United States Pharmacopoeia] 42 compendial methods.”
FDA also says that the forced degradation studies used for another product were not validated.
Additionally, FDA says Jiangsu failed to adequately investigate OOS test results after two investigations failed to identify the source of foreign materials found in batches of one of the company’s APIs.
In response to the citations, Jiangsu said it will stop distributing products manufactured at the site until it has completed a corrective and preventative action (CAPA) plan, which FDA says it will need to verify before resuming distribution.
