FDA inspections after COVID-19

Author’s note: This article was prepared with the help of Paula Pastuskovas, an associate at Husch Blackwell LLP. 

As we continue to adjust to the “new normal” following the COVID-19 public health emergency, pet food companies should expect that the U.S. Food and Drug Administration (FDA) is also returning to normal inspection and enforcement activities. Consequently, pet food companies should be prepared for inspections and know their rights during an inspection.  

Inspections by the numbers

The Food, Drug and Cosmetic Act (FD&C Act) requires that animal food be safe to eat, produced under sanitary conditions, free of harmful substances and truthfully labeled. The Food Safety Modernization Act (FSMA), passed by Congress in 2011, amended the FD&C Act to focus on preventing contamination instead of responding to it. To that end, it requires animal food facilities to implement a food safety plan in which it must conduct a hazard analysis and identify appropriate preventative controls, as well as implement current good manufacturing practices (CGMPs). FDA has the authority to conduct facility inspections to ensure that the facility is complying with FSMA and CGMP requirements.

As previously reported by Petfood Industry, FDA inspections of pet food facilities greatly decreased during the COVID-19 pandemic. To protect the health of investigators and facility employees, FDA generally paused routine, in-person inspections, and instead conducted remote inspections while also conducting in-person “for cause” inspections (usually following a recall or as a part of an outbreak investigation). However, FDA is now more actively inspecting facilities in-person and is expecting to return to pre-pandemic inspection numbers in 2023. 

FDA has been conducting inspections on CGMPs since 2016 and began routine domestic Preventative Control for Animal Food (PCAF) inspections in 2018. Table 1 presents data gathered from FDA’s PC and CGMP Measures tracker, and represents inspections conducted by both FDA and its state regulatory partners. Notably, a majority (87–93% of CGMP and 68–83% of PCAF) of the inspections resulted in “No Action Needed” classifications, whereby no objectionable conditions/practices were found by the agency or, if found, did not warrant further regulatory action.

However, FDA did observe a number of common issues among some animal food facilities. 

Examples of common observations and citations that FDA may focus on during CGMP inspections include: 

• Plant management issues (e.g., unlabeled containers, unsanitary storage areas)
• Improper sanitation of utensils
• Failure to take effective pest control measures
• Missing or incomplete employee training records

During preventative control inspections, FDA observed and commonly cited pet food facilities for: 

• Failure to adopt a written food safety plan
• Inadequate implementation of process or sanitation controls
• Failure to validate controls
• Inadequate hazard analyses

Very few of these citations translated into enforcement cases, likely due to the quick corrective actions taken by pet food companies, though we have seen several recent Warning Letters issued to raw pet food facilities. Notably, FDA has raised concerns in pet food facilities regarding failure to:

• Adequately address hazarding in hazard analysis, such as not addressing pathogens of concern commonly linked to raw pet foods.
• Properly implement process controls throughout the production process, such as not maintaining temperature controls throughout processing for frozen raw pet food.
• Implement any control for a hazard, such as only focusing on biological hazards and not addressing chemical hazards such as vitamin D toxicity in fortified pet foods.
• Validate preventive controls, such as not completing a validation study. 
• Maintain a sanitary plant environment and allowing pathogens to persist in the plant environment. 

What to expect during an inspection

In light of increasing inspections, it is important for facilities to know what to expect during an inspection and how to prepare accordingly. While we anticipate FDA to continue conducting remote inspections, we foresee a sharp increase in in-person inspections. 

During an in-person inspection, FDA will conduct a walkthrough of the facility. The agency may choose to conduct CGMP and PCAF inspections concurrently and may also include other program inspections such as Bovine Spongiform Encephalopathy (BSE) or medicated feed inspections. 

FDA commonly collects environmental samples to determine whether environmental contamination has occurred and, in turn, whether harmful bacteria is present that may contribute to the contamination of the final pet food product. The agency will also request access to records and conduct a thorough review of the food safety plan, sanitation records and training records. FDA has authority to review and copy all records that are associated with the facility’s food safety plan — including the facility’s hazard analysis, descriptions of preventive controls, environmental and product testing records, and corrective action records. That said, note that FDA is not entitled to review or copy recipes, sales information, financial data, product research or consumer complaint information (provided that these are not included or referenced within the food safety plan such as reviewing consumer complaints as a monitoring activity for a preventive control). 

Finally, it is likely that FDA will want to take photographs of the facility during its inspection. Notably, while FDA maintains that it has a right to take photographs during an inspection, neither the FD&C Act nor case law provides definitive authority for FDA to do so.  

To be best prepared for an inspection, the facility should be cognizant of FDA’s FSMA requirements and its applicability to pet food facilities. To that end, the facility should be well-familiarized with its food safety plan and CGMPs. Finally, it will be helpful for the facility to have gathered, and be prepared to provide, the appropriate documentation and understand how it wishes to address agency requests for extraneous documents and photographs. 

Hazard analysis most common issue in pet food inspections

www.PetfoodIndustry.com/articles/10973 

 Briefly: Top 5 takeaways

1. Pet food companies should expect that the FDA is returning to normal inspection and enforcement activities, and should be prepared for inspections and know their rights during an inspection.  
2. FDA inspections of pet food facilities greatly decreased during the COVID-19 pandemic, but FDA is now more actively inspecting facilities in-person and is expecting to return to pre-pandemic inspection numbers in 2023.
3. Examples of common observations and citations that FDA may focus on during CGMP inspections include plant management issues, improper utensil sanitation and failure to take proper pest control measures. 
4. During preventive control inspections, FDA observed and cited pet food facilities for failure to adopt a written food safety plan, inadequate implementation of process controls, failure to validate controls and inadequate hazard analyses.
5. To be best prepared for an inspection, the facility should be cognizant of FDA’s FSMA requirements and its applicability to pet food facilities.