FDA Denies Entry of APIs from Chinese Supplier

Rockville, MD (Sept. 6)-The US Food and Drug Administration has denied shipments of active pharmaceutical ingredients manufactured at a production facility of Kunshan Chemical and Pharmaceutical Company (Kunshan City, Jiangsu Province, China) for violation of good manufacturing practices (GMPs), according to an FDA warning letter Sept. 6, 2007, and posted online Sept. 20.

FDA inspected the facilities of Kunshan Chemical and Pharmaceutical in April 2007 and issued an FDA-483, citing GMP violations for an older production facility, located on Kun Tai Road, and a new site on Provisional Highway in Kunshan City, China. Kunshan Chemical and Pharmaceutical submitted written responses back to FDA to the 483 observations on May 29, 2007. In its Sept. 6, 2007 letter, FDA noted that although many corrections have or will be soon implemented, certain deficiencies are still an area of concern for FDA. These concerns involve deficiencies at the sites for incomplete batch production records for production and control of active pharmaceutical ingredient (API) batches. FDA also notes that the Provincial Highway site’s method-validation documentation did not include appropriate data to verify that the analytical method produced accurate and reliable results. Also, production equipment was not adequately cleaned and maintained in a good state of repair at the Kun Tai Road site. 

While Kunshan Chemical and Pharmaceutical specified that APIs made at the Kun Tai Road site were intended for non-US markets, FDA asserted that several shipments of undisclosed APIs were shipped to the United States as recently as March 2007.

FDA is asking Kunshan Chemical and Pharmaceutical to respond to these issues within 30 days of receipt of the warning letter and is denying any future shipments of APIs manufactured at the Kun Tai Road site into the US.

“Until all corrections have been completed and FDA can confirm compliance with CGMPs, this office will continue to recommend disapproval of any new applications or supplements listing your firm as the manufacturer of active pharmaceutical ingredients,” specified FDA in the Sept. 6 letter. The full warning letter, posted on FDA's website on Sept. 20, may be found here.