Hmmm.. Either the FDA is wrong or you are. It doesn't get any clearer than the below posted on FDA.gov. website. So the question is who should the flock follow? FDA vs 1234
FDA REGULATION OF FOREIGN-MANUFACTURED DRUGS
FDA’s monitoring of foreign-manufactured drugs is based on far more than foreign inspections. To comply with the Food, Drug, and Cosmetic (FD&C) Act, any entity that intends to import drugs into the U.S. must ensure that the drug meets a number of quality and labeling requirements. In the FD&C Act, Congress enacted provisions to create a relatively “closed” distribution system for imported drug products to help ensure the domestic supply is safe and effective by limiting the drugs and biologics that may be imported into the U.S. All “new drugs,” which includes all finished prescription drug products, must be approved by FDA as safe and effective for their intended use. FDA approvals are manufacturer-specific and product-specific, and include many requirements related to the product, such as manufacturing location, formulation, source and specifications of active ingredients, manufacturing controls, the container/closure system, and labeling. Facilities that manufacture drugs for the U.S. market must meet FDA’s current good manufacturing practice (cGMP) requirements.
FDA inspects all API manufacturers for compliance with cGMP prior to the approval of the dosage form’s new drug application (NDA), abbreviated new drug application (ANDA), or biological license application (BLA). If during a domestic or foreign inspection, FDA determines that an imported API fails to meet specifications or is manufactured using unsafe practices, an import bulletin can be used to trigger testing of future shipments, or the drug can be subject to automatic detention at the U.S. border.
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