Overview of FDA factory inspections in detail

FDA factory inspections, as an important means for the US Food and Drug Administration (FDA) to ensure the safety and effectiveness of global medical devices, food, drugs, and other products, have always been an authoritative topic in the field of international medical audits. The FDA is affiliated with the US Department of Health and Human Services (DHHS) and is responsible for the management of drugs, food, biologics, cosmetics, veterinary drugs, medical devices, and diagnostic products nationwide. Through rigorous review and testing, it ensures that these products meet strict safety standards before entering the market, effectively protecting consumer health.




Purpose and Background of FDA Factory Inspection




The core purpose of FDA factory inspections is to verify whether the manufacturing enterprise has complied with the relevant regulations and standards established by the FDA, in order to ensure the safety and effectiveness of the product. These inspections are not limited to domestic companies in the United States, but also cover manufacturers worldwide who export related products to the United States. For medical device manufacturers, QSR820 (recently updated as QMSR, short for Quality System Regulation, located in Title 21, Part 820 of the United States Code of Federal Regulations) is the primary basis for FDA on-site audits. QSR820 provides detailed requirements for the quality management system of medical devices, including design control, production control, corrective and preventive measures, labeling and packaging control, and other aspects.




Frequency and Range of Inspection




The FDA conducts a sampling review of registered medical device manufacturers every year as one of the main ways for them to regulate the aftermarket. The inspection frequency is determined based on factors such as the risk level of the product and the company's past compliance history. Generally speaking, manufacturers of Class I medical devices are subject to random inspections approximately every 4 years, while manufacturers of Class II and III medical devices have a higher frequency of inspections, approximately every 2 years. In addition, if a company's products are found to have problems during customs inspections or if adverse events occur in the United States, the frequency of inspections may further increase.




The FDA's overseas supervision and inspection aims to identify potential medical device issues before products arrive in the United States, assess the compliance status of various enterprise facilities with FDA requirements and medical device standards, and assist the FDA in making decisions on whether medical devices are allowed to enter the United States. These routine inspections not only assess whether the company's facilities comply with applicable US laws, but also ensure that FDA regulated medical devices meet various requirements in the United States.




Preparation and process of inspection




The preparation work for FDA factory inspections is crucial, as it directly affects the smooth progress of the inspection and the quality of the results. Enterprises need to establish a dedicated inspection team in advance, with team members covering multiple departments such as quality, production, research and development, and regulations, to ensure comprehensive preparation. The team needs to conduct in-depth research on the latest FDA inspection guidelines and QSR/QMSR requirements, conduct self inspection against the standards one by one, identify and rectify potential non conformities.




Before the formal inspection, the enterprise should prepare all necessary documents and materials, including but not limited to quality management system documents, product registration certificates, production records, inspection reports, customer complaint handling records, etc., and ensure the authenticity and completeness of these materials. At the same time, it is necessary to thoroughly clean and tidy up the production site to ensure that the production process complies with regulations, and that employees have a full understanding of the FDA inspection process and requirements.




On the day of inspection, the company should arrange a dedicated person to receive FDA inspectors, guide them to visit key areas such as production lines, laboratories, and warehouses, and provide necessary explanations in a timely manner. During the inspection process, enterprises should maintain an open and transparent attitude, actively respond to the questions and suggestions raised by inspectors, and demonstrate the high importance that enterprises attach to product quality and regulatory compliance.




After the inspection is completed, the enterprise needs to patiently wait for the written feedback report from the FDA, develop a detailed rectification plan for the issues raised in the report, and submit it to the FDA within the specified time. After the rectification is completed, if necessary, it is necessary to undergo follow-up audits by the FDA until all issues are satisfactorily resolved to ensure that the company's quality management system continues to meet the high standards required by the FDA.