FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

Recently US FDA announced the expansion of unannounced inspections of foreign manufacturing facilities that produce medicines and medical products and supply them in the United States. The aim of this decision is to align the foreign manufacturing facilities with the domestic ones.

In the past, foreign manufacturing facilities often received an advance notice before FDA inspections, unlike the US manufacturers, who were always subject to unannounced inspections. This difference has raised many concerns about the integrity and effectiveness of the foreign instructions.

FDA Commissioner Martin A. Makary said that we need to eliminate this double standard for domestic and foreign manufacturers. For a long time, foreign companies have enjoyed this double standard by getting an advance notice before facility inspections, while American manufacturers never get any notice before inspection. This double standard ends today.

Implementation and Scope

This FDA decision builds upon its Office of Inspection and Investigations’ Foreign Unannounced Inspection Pilot program, In the past, unannounced inspections were conducted in countries like India and China. By expanding, the FDA wants to bring foreign companies to same level as domestic companies. This is a strong message to global manufacturers to maintain regulatory compliance at every moment, they can be inspected at any time. This new initiative will help to reduce the discrepancies and improve the compliance and quality of global manufacturing.

FDA conducts more than 12000 domestic and 3000 foreign inspections worldwide every year. FDA informs the foreign companies before the audit, but they found serious deficiencies double than domestic manufacturers. FDA is improving its foreign inspection program and policies, including the clarification on policies for FDA investigators to refuse travel accommodations from regulated industries to maintain the integrity of the oversight process.

FDA is urging all foreign manufacturers to review their quality systems, ensure all employees are trained and documents are properly maintained and are always ready for regulatory inspection. The FDA is also encouraging the regulatory agencies of foreign countries to collaborate with the FDA to make these practices successful.

Implications for Stakeholders

This policy change has considerable implications for foreign manufacturers supplying pharmaceutical products in US market. Now, companies must ensure continuous compliance status with FDA regulations because inspection can occur without any prior notice. Failure to permit entry for an unannounced inspection can lead to regulatory actions, including product seizures or import bans.

FDA’s expansion of unannounced inspections for foreign manufacturing facilities is a good step for ensuring the safety and quality of pharmaceutical products entering in us market. By treating foreign manufacturers the same as the domestic ones, the FDA fulfills its commitment to protect American consumers.

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