This is the third in an ongoing series of regulatory updates by Larisa Pavlick, VP, Global Regulatory & Compliance, for the United Natural Products Alliance
As a former Food and Drug Administration (FDA) investigator working out of the Denver district office from 2008-2016, when I would arrive at a facility for the purpose of a GMP inspection and after the introductions, some of the most common questions were:
The truth is, FDA assignments are generated once per year. FDA’s fiscal year (FY) ends on Oct. 31. All assignments for the current fiscal year must be completed by this date. All new assignments for the upcoming FY are pre-planned and are typically distributed to investigators beginning on or about Nov. 1. This is called a work plan.
How did your company end up in the work plan? FDA has a database that includes a list of companies (aka “firms”). This database is called the Official Establishment Inventory (OEI). This database is fed by facility registrations (both Food Facility Registration and Bioterrorism Registration) and data from the FDA Import Operations regarding importation of products or raw materials. Unregistered firms can be manually added to the inventory, based on the discovery of the company by the agency. The OEI is managed at a district level to ensure all firms are audited on a regular basis.
Frequency of inspections
The frequency of your FDA inspection is based on the risk of your products, and the regulatory history of your company. There are two classifications of risk: high or non-high. High-risk product categories will have the most frequent visits by FDA. Food Business News reports, “Food facilities designated as high risk must be inspected at least once every three years, and facilities designated as non-high risk must be inspected at least once every five years. The inspection frequencies are minimums, and some facilities may be inspected more often.”1 The frequency described in this article is the same as my experience while at the FDA.
How FDA determines “risk”
The risk of a food product is classified based on the product type and the type of manufacturing used. For example, a canned food has a higher risk than a bakery product. A product may be classified as high risk if it has been associated with a recall or a foodborne outbreak or emergency in the past five years. During my final year at FDA in 2016, I was told that dietary supplement firms would now be classified as high-risk. This means that a manufacturer, packaging facility, distributor or holding warehouse for dietary supplements will be visited by the FDA at least once every three years. If you have never been visited, you should be anticipating a visit at any time.
Final thoughts on inspections
Afer you have read the references below (the same ones from the “FDA Inspections 101” article)—and I highly encourage you to do so—I will expand on the skills needed to prepare for an inspection. Knowing the agency’s expectation is half of the battle. In these last two regulatory updates, I have tried to provide insights into the typical FDA investigator, the type of training investigators receive, how FDA assignments are generated, including why are you being audited, and I have included key regulatory references.
Next: FDA’s Compliance Program Guide (also known as CPG or CP). The CP is the second most important regulatory reference for you and your staff. I have included a link below to the dietary supplement compliance program. We will cover it in detail in our next article. Until then, read the IOM, Chapter 5, and let me know if you have any questions. Additionally, see the attached list of key inspectional references. Remember to share these documents with your staff.
References and other helpful links
Compliance Program: Dietary Supplements-Import and Domestic (Implementation Date: 03/26/2010) includes Pen & Ink Changes as of 07/08/10 to Parts I and II
An example FDA Form 482 – Notice of Inspection
Investigations Operations Manual Chapter 5: Establishment Inspections
Key Inspectional References
21 Code of Federal Regulations Part 111
PART 111—CURRENT GOOD MANUFACTURING PRACTICE (GMP) IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
21 CFR Part 110: Food GMPs
Biennial Food Facility Registration Renewal (October 1-December 31, 2014)
Food links including labeling
A Food Labeling Guide, Guidance for Industry
The FSMA Technical Assistance Network (TAN) is now operational and providing technical assistance to industry, regulators, academia, consumers and others regarding FSMA implementation. The website is found at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.