Skip to main content

Currently Skimming:

8 Enhancing the Efficiency of Inspections
Pages 237-256

The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.


From page 237...
... As elaborated below, the FDA states that inspections are conducted with the purpose of enforcing regulations or collecting information in a processing or production setting. Instructions to investigators for how to conduct establishment inspections are contained in the Inestigations Operations Manual1 (FDA, 2009a)
From page 238...
... Numerous courses, both web- and classroom-based, are also available to state investigators; however, the FDA has no requirement for state investigators to take them. The training covers such areas as retail establishments, food protection, milk, shellfish, manufactured foods, feed and veterinary medicine, investigation response, incident command systems, rapid response teams, and on-farm investigations (Solomon, 2009)
From page 239...
... Inspectors begin by becoming familiar with the establishment's operations and products, its compliance history, pertinent safety factors, and the reporting requirements for the type of inspection to be undertaken. Other preinspectional activities are described in the Ines­ tigations Operations Manual (FDA, 2009a, Subchapters 5.4−5.9)
From page 240...
... regulations. EFFICIENCY OF INSPECTIONS Based on past authoritative reports alluding to this problem, the committee questioned the efficiency of the FDA's food safety oversight system.
From page 241...
... Others reasons are related to the inspection procedures, which have not changed over time other than to become more burdensome with regard to paperwork and have not been adapted to the complexities of modern manufacturing establishments. The Inestigations Operations Manual has not been reviewed externally to determine, for example, whether it is up to date, overly prescriptive, or otherwise less than ideal.
From page 242...
... The committee supports the partnership of the FDA with others, such as the International Food Protection Training Institute, established in 2009, to deliver career-spanning food protection training for state and local food protection professionals. Federal employees with auditing responsibilities should also be provided with specific training.
From page 243...
... Before microbiological, chemical, and physical analyses became more or less routine, FDA inspectors used personal observations to detect possible problems with the basic hygienic conditions in an establishment and relied primarily on two of the adulteration provisions of the Federal Food, Drug, and Cosmetic Act for authority to take action on any findings of unhygienic conditions.2 The GMPs for foods,3 which include special provisions for infant formulas, were finalized in the 1980s. GMPs form the basis for many international standard procedures and principles (for example, the Gen 2 Federal Food, Drug, and Cosmetic Act of , 342(a)
From page 244...
... Fourth Draft: Frame­ work of the FDA Animal Feed Safety System (FDA, 2010) describes the need to update the GMPs for medicated feed.
From page 245...
... . Currently, only feed mills that produce feed with specific concentrations of medication in the premix need a license and are inspected routinely by the FDA or contract state inspectors.
From page 246...
... During that extra time, the officer sees something in the car that prods him or her to ask the driver for access to the trunk, where drugs are found, making the stop a regulatory/legal activity that will take more time than usual. The Inestigations Operations Manual, developed mainly by ORA, is the primary guidance document on FDA inspection policy and procedures for field inspectors.
From page 247...
... Although the committee did not conduct a review of inspectional procedures, it concluded that such a review is warranted to identify approaches, including risk-based approaches, that could increase the efficiency of the inspection process. Such a review should include examining procedures and techniques employed by other federal, state, and local government agencies, both regulatory and law enforcement, as well as those used in other countries, to determine whether they might be of value to FDA inspectors.
From page 248...
... These occurrences are of concern, especially in cases when delaying a decision could jeopardize public health. CAPITALIzING ON FOOD INSPECTIONS: USE OF STATE INSPECTORS AS PRIMARY FOOD INSPECTORS In addition to the use of a risk-based approach, gains in inspection efficiency would be realized if food safety inspection activities at the federal, state, and local levels were coordinated (see Chapter 7)
From page 249...
... The FDA would provide training to state inspectors, review inspectional procedures, and ensure that state inspections were equivalent to FDA inspections. The FDA could also defer to the states for inspection of animal feed mills.
From page 250...
... Private certification is characteristic of the European food industry, whereas public certification schemes still predominate in the United States, Canada, and Japan (Albersmeier et al., 2009)
From page 251...
... KEY CONCLUSIONS AND RECOMMENDATIONS Irrespective of the potential gains from allocating more funds to the FDA's inspection capacity, the committee concluded that a more basic and valuable exercise would be for the agency's inspection procedures to be reviewed for efficiency. The committee believes that, especially in light of resource limitations, the efficiency of the FDA's inspectional activities could be improved.
From page 252...
... Recommendation 8-1: The FDA should work toward an inspection system in which the frequency and intensity of inspection of each facil ity are based on risk, with minimum standards for the frequency and intensity of inspection of all facilities. To support the establishment of such a system, an outside panel should review the potential legal and cultural roadblocks to streamlining inspections and revise the Inestiga­ tions Operations Manual so as to enhance efficiency and protection of
From page 253...
... Based on the number of food safety inspections already conducted at the state and local levels and on the need for national integration of food safety activities, the committee makes the following recommendation. Recommendation 8-2: As alternative regulatory models emerge, the FDA should evolve toward conducting fewer inspections, instead delegating inspections to the states and localities (including territories and tribes)
From page 254...
... 2009. IFT submitted comments to the Perspectives on FDA's Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009.
From page 255...
... Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA's Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Solomon, S


This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More information on Chapter Skim is available.