Last month, Dukal voluntarily recalled antiseptic swabs and wipes because they might be contaminated with the bacteria Burkholderia cepacia. Jianerkang Medical Dressing made the disinfecting wipes. A July 30 import alert and warning letter issued to the Chinese manufacturer and just posted to the FDA website provides a window into its problems.
During its inspection in September at a plant in Zhixi Town, FDA inspectors found bacterial contamination in wipes tested from two batches that had been manufactured a year apart. The inspectors said instead of using sterile manufacturing procedures, the company was simply testing for contamination after the fact and not always using appropriate tests.
It said in cases where sterilization temperatures fell out of spec, Jianerkang investigated the batches where the products might have been damaged by high temperatures but not when temperatures fell below specification. It also did not sufficiently sample iodine coming in from a supplier to guarantee it was meeting standards.
"It is essential that your firm's topical antiseptic drugs be produced in a manner that is appropriate in view of their intended use. The presence of organisms such as Burkholderia cepacia in a product intended to be used for wounds is unacceptable," the warning letter says.
Of course contaminated wipes are not unheard of and not only manufactured in developing countries. Triad Group last year had its Wisconsin plant shut down and $6 million worth of alcohol prep pads and swabs seized because of bacterial contamination that later was believed tied to some deaths.
With Jianerkang, the FDA says the import alert can keep products from being allowed into the U.S. until Jianerkang brings its manufacturing practices up to standards. It also can prevent approval of other products for sale here, but the agency may have already missed a chance there.
The agency issued approval for Jianerkang's sterile lubricant jelly in April, 7 months after inspectors visited the sterile wipes plant. The FDA 501(K) summary says the product is "to lubricate body orifices to facilitate entry of diagnostic and therapeutic devices when a sterile field is required."
- read the FDA warning letter
- see the FDA recall notice
- get the FDA 501(K) summary
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