The US Food and Drug Administration (US FDA) conducts on-site inspections prior to approving a product for the US market. For drug products, these inspections are called Pre-Approval Inspections or PAIs. Once a product is available for commercial sale the FDA will conduct a Post-Approval Inspection. The US FDA will conduct general inspections every 2-3 years to ensure that the firm remains in compliance with US regulations. The FDA regulates all firms that wish to sell, market, or distribute in the United States. If you plan to market or sell FDA regulated products in the United States, then plan on being inspected by the US FDA.
Does this apply to foreign manufacturers?
Yes, absolutely. While the FDA can not legally shut down a foreign manufacturer (or distributor) they can keep you from importing goods into the United States or offering goods for sale. In short, the U.S. FDA can restrict the importation and marketing of foreign goods into the US. The FDA routinely inspects foreign manufacturers to ensure proper regulations are being followed.
How we can help: Inspection Readiness
We perform Inspection Readiness Activities for both small and large firms. Our clients include pharmaceutical companies, medical device manufacturers, Combination product manufacturers, Contract Service Providers (CSPs), laboratories, GMP warehouses, and distributors. Inspection Readiness Activities include gap assessments, Subject Matter Expert (SME) readiness training, Mock FDA PAI Inspections, review of submission files, and site cGxP training.