A bakery was recently cited for inadequate allergen controls related to sesame, and failure to comply with FSMA preventive control provisions and GMPs. Included among the citations were:
- Allergen cross contact related to the unintended presence of sesame was not fully considered and managed with sanitation not extended to all shared equipment or the sanitation procedure, as written in the Food Safety Plan, not addressing which equipment was to be cleaned nor its frequency. Additionally, sesame residue was observed after sanitation had been completed.
- Environmental pathogen contamination (e.g., Listeria monocytogenes) at areas of exposed RTE food was not identified at all steps where such a hazard exists. Where identified, the preventive controls did not fully include the required management components of monitoring, corrective actions, and verification. Additionally, some records of sanitation activities and corrective actions were missing.
- GMP issues included no corrective actions taken for repeated detections of Listeria species isolates from not RTE areas; and evidence of pest activity including a live mouse, rodent pellets in multiple areas of the warehouse, fruit flies and live flour beetles in ingredient areas.
The addition of sesame as an allergen has proven to be a challenge for many bakeries, but FDA is inspecting bakeries, looking for, finding, and citing the lack of controls for sesame as an allergen. And while they’re there … other areas of noncompliance are sure to be found, cited, and warned.
