FDA Audit Questions

The federal Food and Drug Administration (FDA) is responsible for establishing guidelines for industries that produce or research food and beverages, medical devices, drugs and cosmetics.in the United States. The FDA conducts company audits to determine safety compliance and the accuracy of data. When an audit takes place, it's important to follow all regulations and collect the necessary data. A negative audit can result in the loss of an agency’s research and production privileges, and even a criminal fraud investigation. Knowing the questions to ask before the audit can smooth out the process.

Basic Information Questions

• When the audit is scheduled, contact the FDA and ask for the name and telephone number of the auditor. Also, find out how many days the audit will take. Also, inquire about the names of any additional investigators scheduled to appear at the audit.

Ask Audit Specifics

• Ask for specifics on exactly who or what is under investigation. Do not offer any additional information or argue about the audit. Wait for the answer and make note of all the information given by the FDA.

Ask the Cause for the Inspection

• Ask for information about why the audit is taking place. Avoid giving additional information about why you think the investigation is happening. Is the audit because of a complaint, a warning, policy or procedure issues, or is it just routine?

Ask Who Should be Present

• Ask if the FDA requires certain employees to be present at the audit. Make a list of all the personnel named. Inquire about the day and time they should be present.

Ask About Documentation

• Find out the data and documents that will be required at the audit or if the FDA wants the documents sent beforehand. Collect all the necessary data, but do not include any documents not specifically required. If the FDA needs the data before the audit, send it overnight if necessary. Mail the documents by certified mail to ensure you have a record that that the FDA received the material on time.