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
The engagement covered Lallemand’s Vienna facility, which produces liquid and dry yeast for baking applications, yeast for the fermentation of alcoholic beverages, and an Active Pharmaceutical Ingredient (API) in both liquid and dry forms — a diverse product portfolio with distinct food safety and regulatory considerations under the U.S. FDA framework.
The one-day engagement combined an on-site facility tour with a structured review of existing documentation, assessing potential gaps across the principal components of a compliant Food Safety Plan, including:
- Food safety team qualifications and training requirements
- Qualifications of individuals and supervisory personnel
- Good Manufacturing Practices and prerequisite programmes
- Hazard analysis and critical control points
- Raw ingredient and allergen risk assessment
- Supply chain programme and supplier verification
- Sanitation programme
- Corrective actions and corrections procedures
- Monitoring, verification, and validation procedures
- Environmental monitoring programme
- Recall plan and recordkeeping requirements
The structured gap review provided Lallemand’s team with a clear picture of their compliance status against FSMA requirements and a practical basis for prioritising improvements to their Food Safety Plan ahead of potential FDA scrutiny.
