Inspection Questions and Answers
What is a remote regulatory assessment?
A remote regulatory assessment (RRA) is examination of FDA-regulated establishments and/or their records, conducted remotely, to evaluate compliance with the FDA’s regulations. RRAs help inform regulatory decisions and can help verify information that was submitted to the FDA.
What is an FDA investigation?
The FDA investigations, while limited in scope, are information gathering activity conducted for many different reasons. Some specific types of investigations include complaints, a disaster and health fraud.
What actions does the FDA take when violations are observed during an inspection?
If a facility does not meet current good manufacturing practice standards (CGMPs) upon inspection, the FDA has an array of regulatory tools it can use to encourage a company to remediate their manufacturing processes and achieve compliance. These tools include warning letters, import alerts, injunctions, seizures and civil money penalties.
The agency may request (if we have mandatory recall authority under the law) or recommend a manufacturer recall its products following an inspection. This happens when we observe federal law violations that may impact the quality of the product manufactured at the facility.
If the agency observes on a follow-up inspection that a facility still does not meet CGMP standards, it can escalate the matter as appropriate.
The FDA often meets with manufacturers to discuss inspection findings to achieve more timely and effective corrective action. Sometimes we do this prior to taking formal actions to encourage voluntary compliance with FDA regulations.
If a facility does not meet current good clinical practice (CGCP) or current good laboratory practice (CGLP) requirements upon a clinical or non-clinical research inspection, the agency can take action, such as warning letters, clinical holds, withdrawal of approval, injunctions, disqualifications and civil money penalties.
Does the FDA use inspectional information from its foreign regulatory partners?
Leveraging information from trusted foreign regulatory partners yields greater efficiencies for U.S. and foreign regulatory systems by avoiding duplication of inspections. The FDA has entered into arrangements that allow the agency to redirect inspectional resources to other high-risk facilities for inspection to augment our inspectional capacity.
- For drugs: Mutual recognition agreements between the FDA and foreign regulatory authorities (European Union and United Kingdom) allow the agency to rely upon information from drug inspections conducted within each other’s borders. These agreements allow the agency to recognize drug inspections conducted by foreign regulatory authorities if FDA determined those authorities are capable of conducting inspections that met U.S. requirements (27 E.U. countries and UK; the agency is considering adding other countries). For example, a United Kingdom investigator can inspect a facility in South Korea and we could accept that inspectional information as part of our surveillance activities.
- For devices: The agency participates in the medical device single audit program with other international medical device regulators.
- For foods: The agency has systems recognition agreements with several countries which greatly reduces the number of foreign inspections in these countries and allows the agency to target inspection resources to countries of greater concern. Systems recognition agreements differ from country to country and are applicable to the products agreed to with each respective country.
Does the FDA rely on states to conduct food inspections?
Yes. The FDA contracts with states and territories to conduct inspections of selected food manufacturer/processor facilities to determine compliance with federal law, state law or both. The agency trains the state inspectors who conduct these inspections to ensure consistency in our inspectional approaches.
The agency also provides findings from our inspections to our state counterparts, which aids the states in their understanding of regulated industry and helps create efficiencies with their resources.
Some states also conduct non-contract inspections, which supports the integrated food safety system. States provide the FDA with inspection data via this voluntary program.
Why does the number of inspections fluctuate?
The number of annual inspections in any region or country may fluctuate year-to-year because some inspections occur on a routine basis, while others take place when the FDA is reviewing specific product applications or when the agency receives information about potential product manufacturing or quality problems.