| Many food companies and suppliers have been given | | | | Designated escorts should also be familiar with |
| high ratings by state inspectors and private inspection | | | | appropriate sections of the FDA Investigations |
| services only to later have the FDA uncover serious | | | | Operations Manual, Subchapter 5.4 ( The note taker |
| CGMP deficiencies that had been overlooked. In a | | | | needs to accurately record the investigator’s |
| number of situations these deficiencies have led to | | | | questions and comments and the answers provided. |
| product recalls, serious illnesses, and even death. The | | | | If during the course of the inspection, the |
| Peanut Corporation of America stands out as a | | | | investigator wishes to speak directly to an employee, |
| particularly egregious example (see This three-part | | | | be certain that the question being directed to the |
| series provides a ground level view of FDA | | | | employee is one that the employee is competent to |
| inspections, starting with a discussion of the FDA's | | | | answer, and that the employee’s answer is |
| inspection process and guidance for the conduct of | | | | factual. The employee should not be permitted to |
| the inspection; Part 2 considers the issues that FDA | | | | express an opinion and should confine his/her |
| investigators are trained to cover during an | | | | answers to the question asked. If the question is not |
| inspection; and Part 3 closes the circle with a | | | | appropriate for a particular employee or if the |
| discussion of post-inspectional strategy and | | | | employee is not completely fluent in the language, |
| recommendations for successful inspection outcomes. | | | | the investigator should be so informed. To the |
| When an FDA investigator arrives to conduct an | | | | extent possible, the escort, supervisors, or managers |
| inspection, s/he will present a “Notice of | | | | who are completely knowledgeable about the subject |
| Inspection” (Form FDA 482). If the inspection | | | | should handle questions. |
| involves either low-acid (21 CFR 113) or acidified | | | | Since there are no record keeping requirements in 21 |
| foods (21 CFR 114), the investigator will also present | | | | CFR 110, if the inspection does not involve low-acid |
| a “Demand for Records” (Form FDA 482a). | | | | or acidified foods, investigators are not authorized to |
| Inspection and copying of records for low-acid and | | | | request or copy records unless the records are |
| acidified foods is authorized by 21 CFR 113 and 21 | | | | volunteered by the company. Even though they can |
| CFR 114, respectively. The umbrella food CGMPs (21 | | | | demand records under the Bioterrorism Act of 2002, |
| CFR 110) has no records provision. However, the FDA | | | | it is unlikely an investigator will do so absent a |
| can demand records under the Bioterrorism Act of | | | | compelling reason. Investigators are, however, |
| 2002 ( | | | | instructed to ask for formulas even thought there is |
| Inspections normally begin with an opening meeting at | | | | no requirement to provide either qualitative or |
| which the investigator will discuss the purpose of the | | | | quantitative formulas. If formulas are not provided, |
| inspection, cover administrative details, and provide a | | | | the investigator may attempt to reconstruct them |
| preliminary indication of the course of the inspection. | | | | by observing production, batch cards or formula |
| At least one representative of management and the | | | | sheets, and raw materials and their location. If the |
| inspection escorts should attend the opening meeting. | | | | company does not wish the FDA to have access to |
| It is also advisable for quality and production | | | | its formulas, for whatever reason, it is justifiable to |
| management to be in attendance. During this | | | | keep any formula-related documentation out of sight |
| meeting, the investigator should be asked to clarify | | | | of the investigator. |
| any points that are not clear, and, if the inspection is | | | | Investigators are also instructed to take photographs |
| expected to last more than one day, a meeting | | | | to document violative conditions. Companies, in |
| should be requested at the end of each day to | | | | consultation with legal counsel, should establish a |
| review any inspectional findings up to that point. | | | | position on photographs prior to be confronted with |
| The investigator should be accompanied at all times | | | | a request during an inspection. If the company |
| by two escorts--one to lead and interact with the | | | | permits photographs, the escort should take an |
| investigator and one to take notes. It is important | | | | identical photograph from the same angle at the |
| that both escorts, but particularly the lead escort, be | | | | same time. |
| knowledgeable about plant operations; familiar with | | | | Part 2 of this series focuses on those things FDA |
| the CGMP requirements; and have an understanding | | | | investigators look for and look at during the course |
| of the authority and responsibility of the inspector(s). | | | | of an inspection. |