1. Facility Documentation:
Ensure that all documentation about the facility, such as licenses, certificates of analysis, and safety protocols are up-to-date.
2. Employee Training Records:
Verify that employees have received proper training on handling products and equipment according to FDA regulations.
3. Quality Assurance Programs:
Check that there are good quality assurance programs in place for evaluating product safety and efficacy.
4. Manufacturing Processes:
Make sure all processes meet Good Manufacturing Practices (GMP) standards set by the FDA.
5. Equipment Maintenance:
Confirm that all equipment is regularly inspected and maintained appropriately to prevent contamination or other issues with the product line.
6. Laboratory Testing:
Make sure laboratory testing is conducted regularly to verify product safety and identify any potential issues.
7. Recall Plan:
Validate that a recall plan exists for dealing with product recalls or other situations in which the FDA must be notified.
8. Labeling Guidelines:
Verify that all labeling guidelines are followed, including any changes mandated by the FDA.
9. Sanitation Procedures:
Make sure all sanitation procedures are regularly followed to prevent contamination and other issues with the products.
10. Complaint Handling Process:
Ensure that a process exists for handling customer complaints regarding product safety or other concerns.
11. Documentation Review:
Review all necessary documentation such as batch records, environmental logs, and shipping documents for accuracy.
12. Record Retention:
Verify that records are being stored properly according to FDA regulations, including document retention periods and data backups.