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Environmental Sampling
District ActivitiesNancy Schmidt
Compliance OfficerU.S. Food & Drug Administration
Office of Regulatory Affairs Denver District Office
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AGENDA
• Current emphasis on environmental sampling (ES)• Triggers for District sampling• Sampling process• Post-Sampling communication
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Current Emphasis on ES
• Increased emphasis since 2009 in the food arena based on increased association of certain foods with pathogens and foodborne illness
• Environmental sampling as a tool to identify and control pathogens in the plant
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Triggers for District Sampling
• Outbreak related to pathogen traced back to a manufacturing/processing site
• CFSAN surveillance assignment (data gathering)
• Inspectional findings-Routes of contamination-Sanitation practices-Facility
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Sampling Process• 3 person team
o Aseptic processo Sanitized apparel and equipment,
disposable shoe coverings, etc.o Swabs or sponges
• Assessment of operations and equipmentoMappingo Zone identification
• Firms encouraged to collect “duplicate” samples
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Post-Sampling Communication
• Contact after analysis
• Moving forward to resolve concerns― voluntary corrections
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THANK YOU FOR YOUR ATTENTION