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:
- Alignment between the hazard analysis and the written Food Safety Plan
- Evaluation and documentation of environmental pathogen risks in open-product zones
- Physical hazard controls
- Allergen cross-contact controls and changeover verification
- GMP observations including by-product handling
- and more..
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.
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