10 Factors The FDA Will Use To Assess Your Facility
By Laurel Maloy, contributing writer, Food Online
As FSMA is implemented, the FDA’s inspection schedule will be determined by facility assessment and its high- or non-high risk designation
The following factors will be utilized by the FDA in order to determine a domestic facility’s inspection schedule. Under Section 201 of the Food Safety Modernization Act (FSMA), the FDA is required to designate each facility as high-risk or non-high-risk. This designation will establish the minimum number of times during a specific time period your facility will require an FDA inspection.
Those facilities considered high risk will be required to have one inspection within five years of FSMA’s implementation. From there, that facility will be required to have no less than one inspection every three years thereafter. Non-high-risk facilities will require an FDA inspection once in the seven years following FSMA’s implementation, with inspections occurring at a minimum of five years thereafter. Here is what the FDA will be looking for:
- Recall Or Class I Outbreak
Has your facility ever been involved or linked to an outbreak, recall, or adverse event?
- Product(s) Produced
Are the products being produced in your facility inherently considered at high risk for contamination?
- Sample Testing
Has any product or environmental testing returned positive results for a foodborne pathogen?
- Non-Compliance History
Does your facility have a history of non-compliance as shown on FDA Official Action Indicated (OAI) or Voluntary Action Indicated (VAI) reports?
- Significant Violations
Has your facility been reported as having any significant FDA violations?
- Last Inspection Date
When was your facility last inspected?
- Financial Stability
Is your company financially able to implement and maintain the regulatory requirements demanded by FSMA and the FDA?
- Customer Complaints
Has your facility been at the center of repeated customer complaints?
- Quality Assurance & Control
How robust are your facility’s procedures and programs? Do you provide verification with third-party audits reports? How effective are your company’s risk-based and hazard-analysis programs?
- Food-Safety Culture
Does your facility embrace the beliefs and behaviors necessary to cultivate and facilitate safe food production?
Some factors will be impossible to control, such as the product your facility makes or if your establishment already has a recall or violation history. However, if your facility is not currently on the FDA’s radar, there are a number of steps you can take to improve your FDA profile. For example, all of the last four steps above are actionable. Financial stability can be achieved through critical assessment or the expertise of a financial advisor. If your facility’s financial health is at risk, don’t do it just for the FDA, though this should be a good incentive to get your house in order; do it for your business. The last three items above pretty much go hand-in-hand. Embracing a culture of food safety will lead to fewer customer complaints and will, by default, improve your quality-assurance and -control procedures.
These considerations were all addressed by Roberta Wagner, Deputy Director for Regulatory Affairs at the Center for Food Safety and Applied Nutrition (CFSAN) at the recent Food Safety Consortium. Additionally, Wagner spoke of the FDA’s mandate under FSMA to ensure the safety of imported foods. The FDA currently performs about 1,200 inspections in foreign facilities per year. The new mandate will increase the FDA’s authority, increase its inspection schedules, and enable perusal of Foreign Supplier Verification (FSVP) and Voluntary Qualified Importer (VQIP) records.
FSMA mandates at least 600 foreign inspections during the first year of implementation, with an increase every year for the following five years. The target is for the FDA to conduct 19,200 foreign inspections annually by the sixth year following FSMA’s implementation. Wagner questions the practicality of this mandate in light of the FSVP, as well as the FDA’s questionable financial and personnel resources.
However, while this matter may still be up for debate, foreign facilities will be inspected with a risk-based approach similar to the 10 factors above for domestic facilities. The FDA utilizes a risk-management tool, Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). PREDICT has been fully deployed since mid-2012 and was supposed to replace the FDA’s Operational and Administrative System for Import Support (OASIS) screening system, though OASIS reports are still being generated. PREDICT expedites entry of goods considered to be at low-risk for adulteration, misbranding, or other violations, while those goods at high risk are targeted for increased scrutiny. This attention to detail has elevated the FDA and FSMA to a more favored position in the domestic food processing community.
The consensus is that the FDA is getting it right; global food safety will be a reality, a culture common around the world.