Under the Microscope: Food Industry Sees Increase in FDA Inspections
Food safety is an important issue. About 128,000 people are hospitalized every year due to a foodborne illness, according to data from the Centers for Disease Control and Prevention. Regulatory bodies, therefore, continue to adopt stricter measures to ensure compliance with food safety regulations and guidelines.
In the last few years, the FDA has increased efforts to reduce the number of food safety incidents. The most prominent move was the enactment of the Food Safety Modernization Act (FSMA), signed into law in 2011. More recently, the FDA aims to increase domestic and foreign inspections of regulated products.
FSMA takes a prevention-oriented approach to food safety and requires food processing firms to enforce several preventive controls, such as having a documented food recall plan in addition to a food safety plan. Last year, the FDA announced that it would increase routine inspections of food processing facilities under its jurisdiction, in line with the requirements of FSMA. Affected firms include:
- packers/repackers, and
- holders of foods.
A similar announcement was also made for biological products. Risk-based inspections will replace the usual biennial inspections of drug and biological product establishments.
These announcements should come as no surprise since historical data show a steady increase in the number of food inspections in the last four years. A look at the FDA Compliance Data Dashboard shows that the number of inspections in the food and cosmetics category has risen steadily from a little over 8,500 inspections in 2014 to almost 10,000 inspections in 2017 for domestic and foreign facilities combined. For regulated foreign establishments, a total of 300 and 289 on-site inspections were carried out in 2016 and 2017, respectively, against the 237 inspections in 2015. Of that number, the majority (more than 60 percent) were food inspections.
What does this mean for food businesses?
If your business is FDA-regulated, you should expect an inspection sooner rather than later. It is important to understand the different types of inspections conducted by the FDA and what is expected in each scenario. These include:
- Pre-approval inspections for a new product (in this case, the company is aware of the inspection and is given time to prepare)
- Post-approval inspections after a product has entered the market
- Routine inspection of a regulated facility
- “For-cause” inspections to investigate specific problems brought to the FDA’s attention
Following the new updates, we can expect routine inspections to increase. Companies with no history of food safety incidents are usually notified before a routine inspection. However, if a firm has had a series of safety incidents, the inspection would most likely be unannounced.
Preparing for FDA inspection
The aim of an inspection is to ensure compliance with FDA laws and regulations. This requires a thorough understanding of the rules as it applies to your business and product categories.
During an inspection, investigators gauge a firm’s ability to:
- Follow current good manufacturing practices (CGMP) during production,
- Maintain equipment and facilities in good condition
- Implement process control
- Properly document processes and keep records
- Resolve discrepancies and complaints
To meet these expectations, food businesses can adopt helpful strategies.
Perform mock audits: Here at FoodLogiQ, we have always emphasized the importance of mock recalls in ensuring compliance and food safety. Similarly, mock audits should be performed in preparation for FDA inspections. There’s no better way to prepare for an actual inspection than to simulate one. Access inspection guides for your product categories, study the guidelines and procedures carefully, and set up the systems necessary for a successful inspection.
Invest in staff training: Having a well-trained staff is crucial for success. It is important to identify representatives who will interact with the FDA officials and designate specific roles ahead of time. Non-participating staff should also be updated on inspection procedure.
Look out for the problem areas: A look at some of the FDA citations and warning letters for inspected factories reveals the common problems:
- Lack of HACCP plan implementation or monitoring,
- Poorly trained personnel,
- Incomplete records/documentation, and
- Inadequate traceability measures.
It is good practice to study warning letters issued to closely related businesses and address problem areas relevant to your business.
Adopt the right technology
Beyond food safety, a failed FDA inspection could greatly tarnish a brand’s image and negatively impact revenue. Lack of proper documentation and process controls are some of the major challenges encountered by food companies during an inspection. Adopting the right technology can make it easier to manage food safety audits and ease regulatory compliance.
FoodLogiQ Connect allows food companies to efficiently manage their supply chain and capture all the data needed for a transparent and FSMA-compliant supply chain. With FoodLogiQ, you can compile critical food safety documentation and HACCP plans online in real-time. To learn more about FoodLogiQ’s powerful software solution, request a demo.