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FDA Issues Warning to API Manufacturer


September 29, 2016

The US Food and Drug Administration (FDA) issued a warning letter to the Cheng Fong Chemical in Taoyuan City, Taiwan.

What prompted this action? It came in the wake of an investigation of the facility in April. The agency noted that the company had not created a “maintenance procedure to prevent contamination or carry-over of a material that would alter the quality of the API.”

Further, the company failed to conduct adequate investigations after receiving customer complaints of the presence of black foreign particles.

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Finally, the company had not maintained the cleanliness of the buildings, noting the presence of foul odors, insects, filth, and wet layers of an unidentified material.

The letter was issued September 15.

 

--Stephanie Vaccaro

 

Reference:

US Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations. www.fda.gov. Accessed September 27, 2016.

 

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