Case Study: AIB International Helps Frozen Dough Manufacturer Prepare for FDA Inspection

AIB International has been supporting the process of preparing Gonnella Frozen Dough for Food Safety Modernization Act (FSMA)’s requirements.

AIB‘s latest field service, FDA Preparedness Inspection, delivers a simulated

FSMA-type inspection. AIB’s FDA preparedness inspection addresses these three questions:

• Is your regulatory policy in line with FSMA’s requirements?
• Do your employees understand your plant’s policy for handling regulatory inspections and are they following it?
• Will your updated food safety plan meet FDA’s newest requirements?

Gonnella Frozen Dough approached their Preparedness Inspection with confidence. Alicia Pulings, Quality Compliance Manager at Gonnella Baking Company, set up the mock inspection knowing there were minor gaps in the facility’s FSMA compliance process that they were in the process of addressing. With the exception of two key decision-makers, the visit was unannounced to Gonnella’s staff, including their plant manager.
“Even though it was a test inspection, I could sense our team’s uneasiness and it reminded them that we need to be audit-ready at all times.” said Pulings.
One of the biggest reveals of the FDA Preparedness Inspection was when an AIB inspector collected swabs. Pulings believes this was an eye opener for members of the team, especially those who did not attend a FSMA training.
“Knowing the FDA could collect swabs is new and important,” said Pulings. “We have minor revisions that are needed to a few of our existing programs. During the inspection we learned that the FDA has granted an extension to one of our new programs that is in process of being implemented  — without this simulated inspection we would not have known.”