Food and Drug Administration’s Ongoing Use of Inspectional Tools

The U.S. Food and Drug Administration’s approach to domestic and foreign food and medical product inspections has been deliberate and risk-based. The Covid-19 required a rework of the business operations so that the public health mission could be carried out while protecting the workforce and the other workforces regulated by FDA.

The medical and food manufacturers of FDA-regulated products are usually required to have a quality management system in place. This system is known as preventive controls systems for food safety plans in the food industry. This system ensures the quality and suitability of the product for U.S. Consumers. Inspections are conducted to verify the quality management systems by the FDA. The Food and Drug Administration conducts inspections to note and mandate the corrections wherever required.

On-site inspections represent a key tool in the various parts of a comprehensive approach that has to oversee FDA-regulated products in the pandemic period. The FDA prioritized inspections by identifying those who are “mission-critical” on a case-by-case basis. It was a key to the public health mission, and the activity could not be achieved in any other way.

To extend the reach during the pandemic, the FDA created and implemented new innovative approaches. They utilized the following while entering facilities for inspection:

• Remote assessments for individual program areas to evaluate facility records.
• Use of sampling and analytical testing of Food and Drug Administration-regulated products both domestically and at the border.
• They refused entry of unsafe imported products into the U.S.
• Compliance history reviews of facilities, including recalls and product complaints, to assist with prioritization.
• They leveraged information shared by trusted state, local and foreign regulatory partners through mutual recognition and confidentiality agreements.