Six Solutions for FDA/Industry Cooperation

Departments - Practical Solutions

April 8, 2016

Now is a good time to work more cooperatively with FDA— and a good time for FDA to work more cooperatively with the industry. The industry is facing unprecedented regulations, and FDA unprecedented authority with many new hires. What can we do to better work together? I discussed this with Robert Wilson, president of FDA Regulatory Guidance, retired FDA supervisory investigator, and fellow member of the Strategic Alliance of Food Experts (SAFE). Following are answers to six questions that provide practical QA solutions.

1. What are the changes?

FSMA is affecting the culture of the food industry as well as the feed milling and animal/pet food industries. FDA is changing too, with many routine inspections now conducted under contract by state counterparts such as the departments of agriculture. The FDA field also is changing organizationally. One person may now coordinate all feed milling, all animal/pet foods, and all human foods for more than one district office, with field investigators from several districts reporting to him/her.

2. Why should the food industry work with FDA?

FSMA will require more training for FDA, as well as industry. FDA has announced opportunities for funding, through cooperative agreements, to enhance food safety under FSMA. The agency is working with various organizations anticipating an offering of education and training — be on the lookout for FSMA regional training meetings. The training of FDA personnel will extend to its food safety federal, state, local, tribal, and territorial partners. If industry works cooperatively, a smoother transition can help meet the FDA goal of a “safer” food supply in the U.S., and FDA can help the food industry help rebuild lost consumer trust.

3. What can the industry do to work more cooperatively with FDA?

Since there will be inexperienced FDA investigators in the field, there may be problems with misunderstandings of food manufacturing. To help bring newly hired FDA personnel up to speed, plants could provide them with facility tours, while explaining the industry, process, equipment, and terminology. Although this may be considered a radical concept, it is not uncommon in the pharmaceutical and medical device industries. You also could request a meeting with your FDA contact to discuss HACCP (FDA assigns district HACCP coordinators who can offer expertise). The inspector may ask difficult questions, but that is better done in a preventive approach. Acting in good faith with FDA and expecting the same is not unreasonable. FDA has a job to do — a job that is becoming bigger, especially in the global market.

4. How should the food industry work cooperatively with FDA?

Start with a get-to-know your FDA. Go to your district office for a meet and greet. Inform your contact of notable quality assurance and food safety activities at your plant. Offer an invitation (by appointment) to tour your plant as a guest. By now paranoia has probably set in, but this visit does not come with a notice of inspection, and a courteous exchange should be forthwith. Do the same for your FDA state counterparts who conduct contract inspections.

5. Is your plant ready for an FDA tour?

It should be, but if it isn’t, get it ready now. If your company culture does not allow direct contact with FDA, find an experienced third party to conduct an in-depth evaluation or “gap analysis” of Good Manufacturing Practices and/or FSMA compliance.

6. When should you contact FDA?

It is never too early, but it can be too late. FDA will come. The agency has unprecedented authority, and quality assurance and food safety professionals have big challenges. This is the time for a cooperative approach. If you are having difficulty determining your local, district, regional, and headquarters contacts, visit of the Investigations Operations Manual (IOM). You should have a company representative become familiar with the IOM to help understand FDA and prepare your facility for a visit.

Quality assurance and food safety is going through change. FDA is going through change. Working with FDA should not be something to be afraid of. For the benefit of the food industry and FDA, now is a good time for a cooperative approach.

If your company’s culture has not bought into top-notch quality systems and a HACCP program on the plant floor, your executives and management might not embrace this idea. But, without it, you may experience some long nights due to frequent visits from FDA.

If your plant is not ready, get it ready. The sooner the better; FDA will come.

Ole Dosland is the QA & Food Safety Consultant and Trainer, DOZ Enterprises.