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Regulatory News | 20 December 2016 | By Zachary Brennan
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 8 December to China-based Baoying County Fukang Medical Appliance with six violations.
During the June inspection, FDA says its inspector asked a company representative to “explain the microbiological testing processes” for products manufactured and distributed in the US from the plant, but the representative said that information is protected as a trade secret.
“Our investigator explained that as part of the inspection, FDA needs to know the details of the operations, and that FDA does not disclose details of the information. Nonetheless, without reasonable explanation, the full test procedure was never provided,” the letter reads.
In addition, the FDA investigator “documented copious amounts of unknown black, mold-like material on the floor and walls” of one warehouse and “standing water on the floor and live insects at the entrance of the same warehouse.
“There was no adequate washing facility accessible to working areas at your site. Additionally, the only toilet facility on-site contained visible sewage and had no running water. This toilet facility is shared by production, quality, and administrative personnel at your facility,” FDA warned.
In addition, FDA said the company “receives drums of [redacted] raw material from your supplier without any identifying labels. Your firm does not perform identity testing or any other analysis onincoming raw materials upon receipt or prior to use, and you have no procedure that permits you to trace the source of the [redacted] in each batch of finished products.”
Tags: warning letter, China drugmaker, mold in manufacturing facility