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Regulatory Focus™ > News Articles > FDA Cites Chinese Company for Manufacturing Contaminated Wound Care Products

FDA Cites Chinese Company for Manufacturing Contaminated Wound Care Products

Posted 16 August 2012 | By Alexander Gaffney, RAC 

A warning letter sent to a Chinese manufacturer by the US Food and Drug Administration (FDA) claims antiseptic wipes manufactured by the company were contaminated with several types of dangerous and potentially fatal bacteria.

The 30 July 2012 letter was sent to Jiangsu Province Jianerkang Medical Dressing Co and authored by FDA's Office of Manufacturing and Product Quality, and references a September 2011 inspection conducted by the agency.

The inspection revealed what FDA referred to as, "significant violations of Current Good Manufacturing Practice (CGMP)," related to the facility's finished products.

Dangerous Organisms Found

Specifically, FDA noted testing had confirmed the presence of B. cepacia,Staphylococcus intermedius,  Staphylococcus sciuri and Burkholderia pseudomallei-all of which are potentially fatal to immunocompromised individuals-on antiseptic wipes intended to, "Help prevent infection in minor cuts, scrapes and burns."

"The presence of organisms such as Burkholderia cepacia in a product intended to be used for wounds is unacceptable," chided FDA. The agency also made it clear that it did not think the contamination was only present in the two particular lots identified during its investigation, and called for further testing and a risk assessment.

FDA's warning letter goes on to list several other deficiencies at Jianerkang's manufacturing facility, including its failure to validate its sterilization process or testing methods, failure to institute corrective and preventive action (CAPA) after being made aware of batch specification problems and failure to conduct supportive stability studies on some of its drug products.

FDA 'Concerned' at Response

While the company responded to FDA's original correspondence, FDA noted it was "concerned" about the response.

"It appears that your firm continues to lack an appropriate resolution to significant microbial quality issues relating to your firm's antiseptic drug products," FDA wrote. "Senior management has the responsibility to ensure the quality, safety, and integrity of its products. A fundamental part of this responsibility is assuring timely investigation and resolution of the issues and preventing distribution of defective products."

The firm's products are currently subject to an Import Alert and are not allowed into the US.

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