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General Information
Date of Inspection
Facility Name
Facility Address
Facility Phone Number
Facility Contact Name
Facility Contact Title
Facility Overview
Type of Facility
Products Manufactured
Number of Employees
Facility Square Footage
Facility Operates 24/7
Biological Monitoring Program
Written Biological Monitoring Program in Place
Program Covers all Relevant Areas
Program Reviewed and Updated Annually
Program Includes Routine Environmental Monitoring
Program Includes Trend Analysis
Facility has Identified Qualified Microbiologists
Microbiologists Provide Program Oversight
Facility has Formal Training Program for Associates
Sampling and Testing
Sampling Locations Identified and Documented
Sampling Procedures Documented
Sampling Frequency Documented
Sampling Methods Suitable for Test Methods
Test Methods Validated
Rapid Microbial Methods Used
Facility Maintains Sample Retention Program
Facility Reviews and Investigates Out-of-Trend Results
Documentation and Records
Facility Maintains Complete Sampling Records
Facility Maintains Complete Testing Records
Facility Maintains Corrective/Preventive Action Records
Facility Maintains Trend Analysis Records
Facility Maintains Training Records
Records Reviewed During Inspection
Records Retained per Regulatory Requirements
Observations and Action Items
Observations
Corrective Actions Required
Preventive Actions Required
Inspection Conclusion
