Each year the Office of Regional Operation (ORO) and the Centers within the United States Food and Drug Administration (FDA) create a list of foreign food, drug, and devices manufacturers (whose products are exported to the US) to be targeted for inspection. The FDA determines which foreign firms warrant an inspection based upon: 1) the type of product that the firm manufacturers; 2) whether the firm is in a high risk category; and 3) the firm’s inspection history.
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The FDA released this data illustrating the number of inspections it completed in the 2011 Fiscal Year (from October 1, 2010 to September 30, 2011). All drug manufacturers including manufacturers of active pharmaceutical ingredients (APIs) planning to export their products into the United States have to comply with U.S. FDA regulations—including current Good Manufacturing Practices (cGMP).
Though the regulations are listed in the Code Federal Regulations (CFR) drug companies often have difficulties understanding and adhering to these regulations. Failure to comply with FDA’s regulations can result in a penalty from the U.S. FDA. Registrar Corp has a team of experts that can work with your company and help explain U.S. FDA Drug Regulations.
For questions related to U.S. FDA Foreign Drug Facility inspections or any U.S. FDA regulation, you can contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.