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During an FDA factory inspection for certification, the FDA typically reviews several key aspects to ensure compliance with regulations. These include:

1. Good Manufacturing Practices (GMP): The FDA will assess whether the facility adheres to GMP standards, which include proper quality control, manufacturing processes, and documentation.

2. Quality Management System (QMS): The FDA will evaluate the effectiveness of the factory's QMS, including its ability to monitor and control product quality throughout the manufacturing process.

3. Facility and Equipment: The FDA checks that the factory is equipped with the necessary facilities and machinery to safely and effectively manufacture the device. This includes evaluating cleanliness, maintenance, and calibration of equipment.

4. Personnel Training and Competency: The FDA reviews the training records of employees involved in manufacturing, ensuring they have the proper qualifications and knowledge to perform their duties.

5. Records and Documentation: The FDA will examine records related to production, testing, and quality control to ensure traceability and compliance with regulatory requirements.

6. Product Testing and Compliance: The FDA inspects the factory’s product testing procedures to verify that products meet safety, effectiveness, and quality standards. This includes reviewing test protocols, results, and validation processes.

7. Corrective and Preventive Actions (CAPA): The FDA will assess how the facility identifies, investigates, and resolves issues that arise during production, and ensures corrective and preventive actions are implemented to prevent future problems.

8. Labeling and Packaging: The FDA checks whether the labeling and packaging meet regulatory requirements, including accurate product information, warnings, and intended uses.

9. Compliance with FDA Regulations: Overall, the FDA evaluates whether the manufacturing processes and products comply with applicable FDA regulations, including those for medical devices, pharmaceuticals, or other regulated products.

This inspection is part of the FDA’s premarket approval process, or it may be a routine part of post-market surveillance for ongoing compliance.

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