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Category: Compliance and Regulatory audits

FSMA Gap Analysis for Wolf ButterBack: Strengthening the Food Safety Plan for U.S. Market Compliance

Friday, 26 June 2026 by Dr Faour Klingbeil
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 →
Tagged under: FDA, Food Safety, FSMA, Regulatory compliance

DFK Expands Support for Food Brewer’s Innovative Products

Thursday, 11 December 2025 by Dr Faour Klingbeil
Following a successful year of partnership, DFK is pleased to announce the extension of its collaboration with Food Brewer. Building on the progress and achievements of the past year, the renewed agreement expands our scope of support to include comprehensive regulatory compliance advisory services for Food Brewer’s cell-cultured and plant-based cocoa and coffee products. Under this extended scope, DFK will continue to provide specialized regulatory and quality assurance support, including guidance on documentation, HACCP plan enhancement, labeling compliance, and supplier verification systems. The service package also includes periodic regulatory updates and tailored advisory sessions to assist Food Brewer in navigating emerging regulatory landscapes for innovative food technologies. This collaboration reflects DFK’s ongoing commitment to supporting forward-thinking food companies in achieving compliance excellence and advancing sustainable, next-generation food solutions.
Tagged under: cell-cultured food, HACCP, novel food, Regulatory compliance, Risk assessment

Pre-FDA Inspection Compliance Audit at August Storck KG: Strengthening Food Safety Plan

Thursday, 30 October 2025 by Dr Faour Klingbeil
DFK for Safe Food Environment was engaged by August Storck KG to conduct a pre-FDA inspection compliance audit at their chocolate manufacturing facility in Berlin, producing the Merci and Chouceur brands for the U.S. market. The two-day on-site audit, conducted in October 2025, assessed the facility’s Food Safety Plan (FSP) and supporting systems against the requirements of 21 CFR Part 117, the FSMA Preventive Controls for Human Food rule with specific focus on the regulatory expectations applicable a product category that receives particular scrutiny during FDA inspections. The audit covered the facility’s hazard analysis documentation, preventive controls framework, sanitation programmes, allergen management, environmental pathogen controls, GMP practices, and supplier verification activities. Following the site visit, a detailed written compliance report was issued, identifying gaps and providing targeted, regulatory-referenced recommendations across key areas including: Each finding was accompanied by specific corrective guidance, regulatory references, and practical examples to support the facility’s inspection readiness and the long-term defensibility of their food safety system. This engagement reflects DFK’s deep expertise in FDA regulatory requirements, supporting European exporters in proactively closing compliance gaps before an FDA inspection occurs. Is your facility export-ready for FDA? Contact DFK to discuss a pre-inspection compliance audit tailored to your product and process.
Tagged under: FDA, FOOD EXPORT, Food Safety, FSMA, Regulatory compliance, Risk assessment

BioCraft Achieves Key Milestone in cell-cultured animal food ingredients

Wednesday, 26 March 2025 by Dr Faour Klingbeil
DFK celebrates the collaboration with BioCraft and their achievements! they have been officially registered with Austrian authorities to handle ABP Category 3, marking a significant step forward in the production of cell-cultured animal food ingredients for pet food producers across the EU. Dr. Faour-Klingbeil has been consulted for supporting the BioCraft team to develop a robust HACCP plan tailored to the unique cell-cultured processes in pet food production. This has been an insightful journey, as HACCP in this innovative environment demands patience, adaptability, and a data-driven approach. Dr. Faour-Klingbeil takes great pride to have assisted BioCraft’s team in their dedication to ethical innovation and unwavering commitment to product safety.
Tagged under: Cell cultured meat, Food Safety, HACCP
workshop

USAID TRADE Project: Developing ToT Food Safety Training Curricula, and Training SMEs on Allergen maanagement, Food Safety Culture, US and EU Food Labeling for Export Readiness

Tuesday, 26 March 2024 by Dr Faour Klingbeil
As part of the Export Enhancement Program under the USAID TRADE project, in collaboration with the Food Export Council (FEC), DFK has been dedicated to supporting SMEs and key stakeholders by enhancing their knowledge and capabilities. This initiative, which began in September 2022, continued through multiple training sessions held on: The objective of these sessions was to train and build the capacity of industry delegates and trainers on the FDA requirements under the FSMA preventive controls rule key and topics essential for international trade compliance and food safety, including: This effort continued through 2024 with the development of Trainer of Trainers (ToT) guidance documents, including: Through this project, DFK is empowering SMEs with the critical knowledge and skills needed to meet international standards, fostering safer food products and enhancing export capabilities.
Tagged under: FDA, FOOD EXPORT, Food Safety, FOOD TRADE, FSMA, PCQI, Regulatory compliance

FSMA Preventive Controls Gap Analysis for Lallemand GmbH, Vienna

Sunday, 30 June 2019 by Dr Faour Klingbeil
DFK conducted a one-day FSMA gap analysis audit for Lallemand GmbH in Vienna, assessing the facility’s food safety systems against 21 CFR Part 117 requirements for yeast and Active Pharmaceutical Ingredient production destined for the U.S. market
Tagged under: FOOD EXPORT, Food Safety, FSMA, Regulatory compliance, Risk assessment

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DFK for Safe Food Environment is a food safety consulting business that provides scientific, regulatory, and technical services to food businesses.

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