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FDA Inspections – Ensuring Safety and Effectiveness


The Food and Drug Administration (FDA) inspects manufacturers or processors of FDA-regulated products to determine whether they comply with relevant regulations. The FDA is an agency that oversees the core functions of medical products and organizations related to tobacco, food and veterinary, global regulatory operations, and policies and operations.

The FDA inspection process ensures that health foods are safe, nutritious, hygienic, and properly labeled taking into account the safety of public health and therefore ensures that medicines used for human and animal use are vaccines and other biological products and medical devices safe and effective.

The FDA process also takes into account the radiation safety of electronic products and ensures that cosmetics and nutritional supplements are safe and correctly labeled, helping to regulate tobacco products and accelerate product innovation. Promotes health. FDA inspects manufacturers or processors of FDA-regulated products for compliance with FDA regulations.

FDA inspection procedures include vaccines and pharmaceutical manufacturers, blood banks, food processing facilities, dairies, feed processors, and compounding pharmacies, in addition to facilities that conduct clinical trials on humans and animals, products imported at the border, or Immigration.

Issues and observations to be investigated during the FDA include processing equipment, workers’ practice, food storage / display, water supply, and plumbing and pest control.

Due to the fact that all FDA regulated facilities are undoubtedly under the FDA, it is imperative that employees receive regular training on what to expect during the FDA process and what their role should be.

There are FDA inspection training courses designed to teach the student basic practices during the FDA inspection. The FDA inspects the necessary preparations before inspecting the inspection and identifies pre-inspection issues and various elements of a Hazard Analysis Critical Control Point (HACCP) plan, to be reviewed during the retrospection.

The FDA process also reviews the basics of handling an FDA pharmaceutical and/or medical device manufacturing facility and will clarify the roles and responsibilities of the personnel during the inspection, with an emphasis on maintaining a positive, professional relationship with the FDA.

The purpose and focus of each type of FDA inspection depend on the main inspection objectives. For pre-approval inspections, after a company submits an application to the FDA to market a new product, the discussion focuses on the process and documentation related to raw materials, manufacturing processes, finished products, and compliance. For post-approval inspection, the discussion focuses on general GMP compliance issues. The FDA also has regular inspections of a regulated facility to investigate a specific issue that is conducted once every two to three years.

2020-09-08