Warning Letter and Import Alert for Chinese Manufacturer
The FDA inspected Baoying County Fukang Medical Appliance Co., Ltd., a Chinese drug manufacturer in Yangzhou City, from 6 through 9 June 2016. Besides serious violations of GMP regulations, the inspector was granted only limited access to some areas or no access at all. The violations and the restricted inspection led to a Warning Letter and a U.S. import alert as of 20 September 2016.
The Warning Letter focused on six key issues:
During an inspectional walk through the laboratory, the inspector wished to have a microbiological test procedure explained to him. This was refused with reference to "trade secrets".
The company had no written procedures for production and quality unit responsibilities. Furthermore, their quality unit approved and released products for distribution to the U.S. market without knowing whether they met specifications and whether they were manufactured under adequate controls.
The company did not perform microbiological analysis of their final products prior to release to the U.S. market. Moreover, they did not perform assay testing for their OTC drug products to verify the identity and strength of the active ingredients prior to release.
The inspector documented copious amounts of an unknown black, mould-like material on the floor and walls of a warehouse. In addition, he observed standing water on the floor and live insects at the entrance of the same warehouse.
There was no adequate washing facility at the site. The only toilet facility on-site had "liquid" on the floor and no running water. This toilet facility is shared by production, quality, and administrative personnel.
The company received drums of raw material from a supplier without any identifying labels. The company did not perform identity testing or any other analysis on incoming raw materials prior to use. They also had no procedure permitting to trace the source of the raw materials in the finished products.