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…