FDA inspectors will look for allergen cross-contact and microbial cross-contamination during inspections.

SCOTTSDALE, ARIZ. — In the realm of the Food Safety Modernization Act (FSMA), good manufacturing practices (GMPs) are the key to survival. As wholesale bakers and other food manufacturers prepare their operations for potential visits from Food and Drug Administration (FDA) inspectors, the American Bakers Association (ABA) has advice for bakers on where to focus concerns for preventive control inspections. 

“We know they’re looking at the modernized GMPs, and they’re limiting that scope to Part 110 for their inspections,” noted Lee Sanders, ABA’s senior vice-president, government relations and public affairs. “There’s a broad assessment for preventive controls.” 

Ms. Sanders recently spoke to the American Pie Council at the National Pie Championships in Orlando, FL, and to ABA members at the association’s annual convention in Scottsdale, AZ, April 15-17.

Improper hand-washing was cited as a top FSMA violation found in bakeries.

Food manufacturers should expect FDA inspectors to be on the lookout for allergen cross-contact and microbial cross-contamination. Ms. Sanders noted that a full preventive control inspection can last upwards of five days. “That’s the average time we’re hearing from our members,” she observed. 

“If you have a facility without an environmental monitoring program in place, and you have raw materials and a ready-to-eat food exposed in that environment, you can anticipate a full preventive control inspection,” she said.  To-date, FDA has conducted 500 broad assessment inspections and about 140 full preventive control inspections, 40 international and 100 domestic. 

At ABA’s convention, Rasma Zvaners ABA’s vice-president, regulatory and technical services, spoke to attendees about FDA’s three tiers of inspections, including regular GMP inspections, general FSMA inspections and FSMA training inspections, in which FDA will bring new inspectors into a facility. While GMP inspections typically run about three days, FSMA inspections can take up to five days, and training inspections can take as long as a week. 

Ms. Sanders noted ABA’s Top 5 observations — based on information in previous FDA 483 forms that have been filed from inspections at ABA member plants — on what FDA inspectors will be on the lookout for during preventive control inspections.

1. Deviations from written sanitation procedures including those from allergen and pathogen procedures. 

2. Missing information from hazard analysis or failing to identify a hazard. 

3. Verification of effective sanitation and environmental monitoring.

4. Proper personnel practices including attire and hygiene such as hand-washing. 

5. Sanitary equipment design that avoids allergen cross-contact and microbial contamination. 

ABA recently updated its inspection manual that is available to ABA members and non-members for a minimal cost. “It’s going to give you an idea of what to think about and give you a check list as you get ready for inspections, both on the food safety side as well as the nutrition facts label side,” Ms. Sanders noted.  

As inspections become the everyday reality, Ms. Zvaners said that FDA is open to hearing feedback on the process. “I’ve heard positive feedback on inspections that went really well with very competent inspectors,” she said. “But I’ve also heard about cases where inspectors weren’t quite up to speed on what they should have been, or things weren’t as effective as they could have been, and FDA is very open to hearing that, as well. They’ll hear our calls and take our feedback, especially when it relates to food safety.”

When speaking to FDA on behalf of members, ABA keeps company names confidential. FSMA is not something that will go away, and ABA is helping streamline the process as much as possible and serve as a shield of defense for the baking industry. 

“Whether it’s for FDA or any other agency, ABA member companies can think of us as an extension of their office in Washington, D.C.,” Ms. Sanders said. “Bakers can call on us and ask for our insight and guidance, and we’re happy to assist.”