FDA Inspections of Food Plants – Part 1 The Inspection Process

Many food companies and suppliers have been given high ratings by state inspectors and private inspection services only to later have the FDA uncover serious CGMP deficiencies that had been overlooked. In a number of situations these deficiencies have led to product recalls, serious illnesses, and even death. The Peanut Corporation of America stands out as a particularly egregious example (see www.nytimes.com/2009/03/06/business/06food.html). This three-part series provides a ground level view of FDA inspections, starting with a discussion of the FDA's inspection process and guidance for the conduct of the inspection; Part 2 considers the issues that FDA investigators are trained to cover during an inspection; and Part 3 closes the circle with a discussion of post-inspectional strategy and recommendations for successful inspection outcomes.

When an FDA investigator arrives to conduct an inspection, s/he will present a “Notice of Inspection” (Form FDA 482). If the inspection involves either low-acid (21 CFR 113) or acidified foods (21 CFR 114), the investigator will also present a “Demand for Records” (Form FDA 482a). Inspection and copying of records for low-acid and acidified foods is authorized by 21 CFR 113 and 21 CFR 114, respectively. The umbrella food CGMPs (21 CFR 110) has no records provision. However, the FDA can demand records under the Bioterrorism Act of 2002 (www.fda.gov/oc/bioterrorism/Bioact.html).

Inspections normally begin with an opening meeting at which the investigator will discuss the purpose of the inspection, cover administrative details, and provide a preliminary indication of the course of the inspection. At least one representative of management and the inspection escorts should attend the opening meeting. It is also advisable for quality and production management to be in attendance. During this meeting, the investigator should be asked to clarify any points that are not clear, and, if the inspection is expected to last more than one day, a meeting should be requested at the end of each day to review any inspectional findings up to that point.

The investigator should be accompanied at all times by two escorts--one to lead and interact with the investigator and one to take notes. It is important that both escorts, but particularly the lead escort, be knowledgeable about plant operations; familiar with the CGMP requirements; and have an understanding of the authority and responsibility of the inspector(s). Designated escorts should also be familiar with appropriate sections of the FDA Investigations Operations Manual, Subchapter 5.4 (www.fda.gov/ora/inspect_ref/iom/pdf/chapter5.pdf). The note taker needs to accurately record the investigator’s questions and comments and the answers provided.

If during the course of the inspection, the investigator wishes to speak directly to an employee, be certain that the question being directed to the employee is one that the employee is competent to answer, and that the employee’s answer is factual. The employee should not be permitted to express an opinion and should confine his/her answers to the question asked. If the question is not appropriate for a particular employee or if the employee is not completely fluent in the language, the investigator should be so informed. To the extent possible, the escort, supervisors, or managers who are completely knowledgeable about the subject should handle questions.

Since there are no record keeping requirements in 21 CFR 110, if the inspection does not involve low-acid or acidified foods, investigators are not authorized to request or copy records unless the records are volunteered by the company. Even though they can demand records under the Bioterrorism Act of 2002, it is unlikely an investigator will do so absent a compelling reason. Investigators are, however, instructed to ask for formulas even thought there is no requirement to provide either qualitative or quantitative formulas. If formulas are not provided, the investigator may attempt to reconstruct them by observing production, batch cards or formula sheets, and raw materials and their location. If the company does not wish the FDA to have access to its formulas, for whatever reason, it is justifiable to keep any formula-related documentation out of sight of the investigator.

Investigators are also instructed to take photographs to document violative conditions. Companies, in consultation with legal counsel, should establish a position on photographs prior to be confronted with a request during an inspection. If the company permits photographs, the escort should take an identical photograph from the same angle at the same time.

Part 2 of this series focuses on those things FDA investigators look for and look at during the course of an inspection.