In a medical product manufacturing  organization, the responsibility for ensuring cGMP (current Good Manufacturing Practice) is being met and the risk of  regulatory observations falls on multiple parties, including:

1. Quality Assurance (QA) department – The QA department is responsible for ensuring that all manufacturing processes and procedures comply with cGMP regulations. They perform routine inspections, audits, and quality checks to ensure that the products manufactured are safe, effective, and meet required standards.
2. Quality Control (QC) department – The QC department is responsible for testing raw materials, in-process samples, and finished products to ensure they meet the required specifications. They work closely with the QA department to ensure all processes and procedures comply with cGMP regulations.
3. Production department – The production department is responsible for carrying out the manufacturing processes in compliance with cGMP regulations. They ensure all equipment is properly maintained, calibrated, and validated. They also ensure the manufacturing processes are properly documented and all necessary records are maintained.
4. Regulatory Affairs (RA) department – The RA department is responsible for ensuring all products and processes comply with FDA regulations. They work closely with the QA department to ensure all necessary regulatory submissions are made.
5. Senior Management – The senior management is responsible for ensuring all departments are operating in compliance with regulations. They are ultimately responsible for the overall quality of products manufactured and compliance of the  organization with FDA regulations.

It is important to note compliance with regulations is a shared responsibility and requires the cooperation and involvement of all departments. By ensuring all processes and procedures are in compliance with regulations, risks are minimized.