This Guidance for Addressing FDA Inspections of Food Ingredient and Dietary
Supplement Facilities has been prepared to assist AHPA members in understanding
their rights and obligations when the U.S. Food and Drug Administration (FDA)
conducts an inspection of a facility in which food ingredients or dietary supplements
are manufactured, processed, packed or held. It provides descriptions and analyses of
the current federal laws that are relevant to inspection of food ingredient and dietary
supplement facilities and suggestions of how to prepare for and conduct inspections in
a manner that fully complies with these laws.
FDA’s inspection authority and procedures are different for each of the various classes
of consumer goods over which that agency holds jurisdiction. FDA inspects most food
ingredient facilities, whether the ingredients are intended for inclusion in conventional
foods or in dietary supplements, in accordance with the regulation for current good
manufacturing practice (cGMP) for manufacturing, packing and holding human food,
as codified at Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110).
Finished product dietary supplement companies are inspected to comply with the
cGMP regulations for manufacturing, packing, labeling or holding dietary supplements,
which are found at 21 CFR 111.
This Guidance is therefore based on FDA’s cGMP rules for inspecting foods with
respect to ingredient manufacturers, and is based on FDA’s cGMPs for dietary
supplements for companies that manufacture, pack, label, or hold dietary supplements.
There are, however, additional requirements that apply to certain food and dietary
supplement classes (e.g., infant formulas; acidified foods; low-acid canned foods; and
fish and fishery products3), as well as to drugs and medical devices. Companies that
also manufacture, process, pack or hold products such as acidified supplements and
fish-oil supplements, or homeopathic and other nonprescription drugs, may therefore
need to understand regulations that are not addressed herein.
This Guidance is provided in four sections, presented in a question and answer format,
and two appendices. These are:
- Part 1 is an overview of FDA’s inspection authority, which derives from the
Federal Food, Drug and Cosmetic Act, the Public Health Security and
Bioterrorism Preparedness and Response Act, the Dietary Supplement and
Nonprescription Drug Consumer Protection Act, the Reportable Food Registry
requirements of the Food and Drug Administration Amendments Act, and the
food and dietary supplement cGMPs (i.e., 21 CFR 110 and 111).
- Part 2 is the shortest but perhaps most essential section of this Guidance, as it
provides suggestions on the steps that a firm should take in advance to be
prepared for an FDA inspection.
- Part 3 provides guidance on what should be expected during an inspection by
- Part 4 discusses the observational findings that follow an inspection and the need
to maintain a thorough internal record of each inspection.
- Appendix 1 is a template for establishing a written standard operating procedure
for FDA inspections. This template incorporates much of the information
contained in the main section of this Guidance.
- Appendix 2 provides the relevant text of the laws and regulations upon which
FDA’s inspection authority is based.
In addition, any company using this Guidance should be aware of the cGMP
regulations that apply to its specific operations, as these form the primary basis upon
which most inspections are conducted. It is a good practice to print copies of these and
maintain them in files that are readily accessible during an FDA inspection. As already
noted, for food ingredient facilities the relevant rule is 21 CFR 110 and for dietary
supplement facilities it is 21 CFR 111 (though see footnote on prior page for other parts
of the rules that apply in some facilities).
Because federal laws and regulations can be amended from time to time, it is important
to be aware of any such amendments and to understand the current status of all
relevant rules. Users of this Guidance must also pay attention to the disclaimer on the
cover page of this document.
Member price: $220
Non-member price: $520