FDA inspection

An FDA inspection can happen at any time in any city or state. The Investigations Operations Manual (IOM) is the primary source regarding Agency policy and procedures for field investigations. It directs the conduct of all fundamental field investigational activities. The mission is to protect consumers and enhance public health by maximizing compliance of FDA regulated products and minimizing the risk associated with those policies.

The scope of consumer protection is extended by cooperative efforts of federal, state and local agencies and international cooperation. Occasionally there are joint FDA-State or local inspections. Collecting samples is a critical part of the FDA’s regulatory activities. A Notice of Inspection (FDA 482) is not always required for sample collection.

The law requires issuing a receipt describing any samples obtained during the course of an inspection. A valid sample is the starting point and keystone for most administrative and legal action. As evidence, the sample must support the government’s charge there is a violation of the law. An official sample is one taken from a lot for which Federal jurisdiction can be established. With a “documentary” (DOC) sample, no actual physical sample of the product is taken. An inspector collects a DOC sample when an actual physical sample is not practical.

An “undercover buy” is an official sample. In an “undercover buy” the solicitation is made in person, usually under an alias. “Undercover buys” are frequently used to investigate complaints of illegal activity. Import samples are physical sample collections of products that originate from another country, collected while the goods are in import status. Import status ends when Customs clears an entry for the shipment

For establishment inspections, after showing the company’s representative credentials, issue the original, properly executed, and signed FDA 482, Notice of Inspection. When the inspection is complete and before leaving the premises provide the highest management official inspectional findings on an FDA 483 – Inspectional Observations.

There are FDA inspection guidelines that pertain to Import procedures. That is Chapter 6 of the IOM. Chapter 7 is all about Recalls. A Recall is a company’s removal or correction of a marketed product that the FDA considers to be in violation of the law. The specifics of an FDA recall is elsewhere on this website.

An investigation is an information gathering activity conducted for many different reasons. The purpose of any investigation is to determine and document facts concerning a particular issue so the FDA can make informed and sound decisions. Some of the specific types of investigations are:

• A complaint investigation
• A disaster investigation
• A health fraud investigation
• A product tampering investigation

Investigations are different from inspections because usually there is no need to issue an FDA 482. Reporting an investigation is almost always done using a memorandum. The memorandum should:

• Summarize the action
• Give the reason for the investigation
• Briefly state the findings.

An FDA inspection is a documented event by a federal official or a state or local official. The Investigations Operations Manual covers all the information needed by an inspector.

Written by: Margaret Stenerson

10 8 2010