FDA Audit Preparation

The Food and Drug Administration, or FDA, is responsible for inspecting businesses that provide FDA-regulated products, such as foods and medicines. It also inspects laboratories and sites where clinical trials are conducted to ensure regulations are being properly enforced. The investigations generally follow the same process, and preparing for the inspection is fundamental to the success of a business's products.

Expectations

• The FDA is required to provide credentials and a written notice (Form 482) in order to enter the facility for an inspection. The inspection, which can be scheduled ahead of time or without prior notice, can be comprehensive of the entire facility or focus on a single aspect of the facility. Investigators may ask to see documentation, equipment, speak to employees or collect product samples. Observations will be documented and submitted to the business.

Preparation

• Preparation for an FDA audit is an ongoing process, but immediately prior to an inspection the business should ensure that employee training is up to date and that a designee for interaction with the FDA is identified. The company should also train the designees on effective interaction with the agency and begin familiarizing themselves with the standard operating procedures (SOPs). Finally, mock inspections are a great way to prepare a team and identify weaknesses at the facility prior to an FDA inspection.

Key Ideas

• The most critical element to a successful inspection is communication with the regulatory authorities. Communication should be professional and clear and never argumentative, hostile or uncooperative. Businesses should wait for an investigator to request information before providing large amounts of details. The company should also be prepared to respond to FDA comments promptly.