Background- A recent FDA inspection happened at a PA non-licensed for medications feed mill. The inspection took place over the course of two days, a Wednesday and Friday during the same week. The inspector was from the FDA as opposed to a PA Department of Ag employee under contract to the FDA. The inspection was a comprehensive inspection covering everything except BSE since the firm only manufactures poultry feed.
The Inspection
The first day of the inspection covered background information about the mill and its operations. Two main parts to this involve establishing that the mill is engaged in interstate commerce and whether it would be a qualified facility. We have yet to find a mill that can claim it does not engage in interstate commerce. All it would take to be considered interstate is to purchase one ingredient from out of state. The firm has sales that surpass the threshold to be a qualified facility.
Side note: If your firm is currently a qualified facility please be sure to complete the attestation form and submit it to the FDA biennially. The inspector noted that most of his inspections of qualified facilities reveal that the submission has not be done.
The inspector reviewed VFDs, the recall program and qualified individual training. He pushed for annual employee training inferring that it is a requirement under the regulations. This is a requirement under the Produce rules, but is not under the rules for human or animal food. We recommend annual training as a best practice, but it is not an FDA requirement.
At the end of the first day, he requested a copy of the Food Safety Plan (FSP) and Hazard Analysis (HA), which we provided to him. He noted that the document seemed a bit light and that he assumed that we kept SOPs separate from the FSP. Learning that was the case he said he would want to look at any of the SOPs that we established to control hazards noted in the HA.
The second day of the inspection involved a discussion regarding the HA and the inspector asked to review certain SOPs like the Supplier Approval Program, Bulk Ingredient Receiving, Mycotoxin Testing, and Magnet Inspections. The inspector told us that he focuses on mycotoxin control and foreign materials as the main hazards for non-licensed medicated facilities.
He also conducted a facility inspection on the second day. He focused on the medication storage area and the inventory log questioning how it is maintained and reviewed. He evaluated housekeeping and the housekeeping logs. The mill was clean which is typical for the facility. He had questions about mill areas listed on the log that were not marked as completed. We explained that in some cases the area might have been cleaned previously and at the next scheduled cleaning time was still clean. In other cases, employees may have cleaned but did not fill out the log. He also wanted to see a sign off of the log by a qualified person or the PCQI.
At the closing of the inspection, the inspector stated that the inspection would be classified as NAI or No Action Indicated. He had a few discussion items that would be noted in the report. All in all it was a satisfactory outcome for the mill.
A Few Key Reminders
- Consider setting up a process for annual training. In a previous FSMA Friday we noted that it was important to make sure that new employees were trained in Food Safety and Hygiene practices before doing any activities in the mill with an impact on food safety. We recommended the Kansas State Qualified Individual Training video for this training. This same video could be used for annual “refresher” training. We have had other inspectors press for annual training and it is often a requirement during third party audits.
- Establish a review process for housekeeping documentation and have a manager or supervisor sign off on the documentation.
