Six Asian Firms Blocked for Refusing FDA Inspections
Four Chinese, one Indian and one South Korea-based drug manufacturer have been added to the US Food and Drug Administration’s (FDA) import alert list in August for failing to allow inspections.A company’s addition to what’s known as the “red list” means that they can no longer ship product to the US.
As FDA explains, “The refusal to permit inspection of a foreign facility or provide reasonable access to FDA's inspectional personnel, combined with other evidence, provides an appearance that the firm's products are manufactured, processed, or packed under insanitary conditions.”
The Food and Drug Administration Safety and Innovation Act (FDASIA) notes that companies that delay, deny or limit an inspection, or refuse to permit entry or inspection, can have their products declared adulterated. The lack of inspection also may mean time wasted for the few FDA employees based in those countries.
As of 14 August, FDA told Focus that FDA’s India office has 14 US direct hires on staff (of which six are currently deployed to India while others await deployment) and five locally employed staff. But not all India office employees are investigators, and India office staff who perform inspections share the inspectional burden with FDA investigators based in the US who travel to India on temporary assignments.
And as of 14 August, FDA’s China office had 20 US direct hires on staff, with six waiting deployment and six locally employed staff. That compares with a previous tally from December 2015, when FDA told Focus the agency had 17 employees assigned to its Beijing office.
Although the specifics of what the companies have done remains unknown, the companies added to the red list in August were:
- Chifeng Wanze Pharmaceutical Co.
- Guangdong Jiaying Pharmaceutical, Ltd.
- Shenyang Funing Pharmaceutical Co.
- Guangdong Guangliang Industry Co.
- India’s Gpt Pharmaceuticals Private
- South Korea’s Dongkook Pharmaceutical Co.