Dr Faour-Klingbeil was engaged by Wolf ButterBack KG, a leading bakery manufacturer based in Fürth, Germany, to conduct a comprehensive gap analysis in support of their alignment with U.S. FDA requirements under 21 CFR Part 117, the FSMA Preventive Controls for Human Food rule.
The engagement was structured around an on-site audit day, during which DFK assessed the facility’s existing food safety programme against the regulatory requirements of a compliant Food Safety Plan, including hazard analysis, preventive controls, monitoring procedures, corrective actions, verification, recall plan and recordkeeping.
Following the audit, DFK conducted a thorough review of the facility’s documentation, examining food safety plans, including their GMPs, sanitation, process, supplier and allergen preventive controls.
The engagement concluded with the issuance of a detailed written report presenting areas for improvement, each accompanied by legal reference and the targeted, practical recommendations and solutions to support the facility’s path to full compliance. The report served as a structured roadmap for Wolf ButterBack’s quality team to prioritise and implement the necessary corrective actions.
This project reflects DFK’s commitment to supporting food manufacturers in meeting U.S. regulatory requirements and bridging the gap between EU and private food safety standards and the specific demands of the FDA’s FSMA framework for export-ready operations.
Interested in a FSMA compliance gap analysis for your facility? Contact DFK →
