FDA Inspection Readiness
FDA Inspection Readiness. 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.
A important element to any product approval or facility registration is Inspection Readiness. Inspection Readiness ensures that your people, documentation, records and physical site are ready for the FDA inspection.
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
We perform Inspection Readiness activities for both small and large companies around the world. Our clients include producers, distributors, and testing laboratories for pharmaceutical products, medical devices, IVDs, biologics, OTC products, and combination products. We work with your company to develop a customized Inspection Readiness plan based on your product and site needs.
Inspection Readiness activities may include:
- Gap Assessments,
- Subject Matter Expert (SME) Readiness Training,
- Mock FDA PAI Inspections,
- Review of FDA Submission Files,
- Document and Record Preparation,
- GMP training,