The Food Safety Modernization Act (FSMA) — signed into law in 2011 — greatly expanded the US Food and Drug Administration’s (FDA) authority to regulate the food and feed supply. Each facility covered under the law now is expected to be in compliance with the requirements of the agency’s final rule for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Animal Food Rule) and is subject to surveillance inspections.

National Grain and Feed Association (NGFA) Senior Vice President of Feed Services David Fairfield answered some questions about the inspection process.


David Fairfield, senior vice president of feed services at NGFA
Q: What types of facilities are subject to inspection?

Fairfield: The FSMA-related Animal Food Rule generally applies to both domestic and foreign facilities that manufacture, process, pack or hold animal food that is intended for consumption within the United States. Types of facilities covered by the regulations may include: feed and feed ingredient manufacturers, pet food manufacturers, grain processors, and biofuels producers that manufacture co-products like distillers dried grains for use as feed ingredients. Under its inspection authority, the FDA is authorized to enter any of these covered facilities “in which food [is] manufactured, processed, packed, or held” and inspect “all pertinent equipment, finished and unfinished materials, containers, and labeling thereon.”


Q: What will the FDA be checking for during inspections?

Fairfield: In general, FDA compliance inspections will focus on the practices and procedures the facility has in place to ensure the safety of food products that it handles.

FDA investigators have the authority to inspect facilities to evaluate whether human food, animal feed and pet food, and grain are being stored, processed, packed and distributed in accordance with applicable provisions of the Federal Food Drug and Cosmetic Act (FFDCA) and its associated regulations, including those that are FSMA-related.

Depending on its operations, a facility in the grain and feed industry could be subject to several FSMA rules, including preventive controls for animal food, preventive controls for human food, and sanitary transportation of human and animal food.


Q: How can facilities prepare for an inspection?

Fairfield: Firstly, facility managers should be familiar with the regulations and how they apply to their operation. They should train the appropriate employees, develop programs that demonstrate compliance — including record keeping — and have an inspection plan in place.

A comprehensive plan to prepare for an inspection should address the potential scope of the inspection, questions an FDA inspector may ask, and guidelines on handling record requests.

Importantly, for facilities subject to the FSMA Animal Food Rule, all individuals that manufacture/process, pack or hold food at the facility are to receive documented training on how to perform their duties in a manner that assures food safety. Also, each facility covered by the preventive controls requirements associated with the Animal Food Rule is required to have a Preventive Controls Qualified Individual (PCQI) who has the responsibility for developing, implementing and overseeing the operation’s written food safety plan. Note that the FSMA Animal Food Rule has two distinct definitions for a “qualified individual” and a PCQI.

Finally, it’s very important for facilities to establish and maintain required records. All of the FSMA rules have provisions that specifically require certain procedures and activities to be documented. The FDA has the right to access, review and copy any required record. Having all of these required records in place is essential for a facility to demonstrate compliance. Facilities should include in their inspection plans which records the investigator would be allowed to access and copy.


Q: What happens if the FDA finds a violation?

Fairfield: FDA uses Form FDA 483 — Inspectional Observations — to document what an investigator believes are objectionable matters observed during an inspection. After issuance of Form FDA 483, the agency allows 15 days for companies to respond in writing to such observations. FDA must receive the company’s written response within the allotted time period for it to be considered when the agency determines whether to initiate enforcement action based on the observations.

If FDA believes it is warranted based upon the inspection findings, the agency may issue a “Warning Letter” to the facility. FDA uses Warning Letters for violations that may lead to enforcement action if they are not corrected promptly and adequately. For any Warning Letter received, the facility should provide a response back to FDA within the specified timeframe on how it intends to address the alleged violations.

Facilities should take FDA’s documented observations seriously and always follow through on actions that it indicates to FDA will be taken to remedy non-compliant conditions. Otherwise, depending upon the significance of the non-compliant condition, FDA may initiate further enforcement actions, such as seizures, injunctions or consent decrees.

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