FDA483 is a nonconformity report issued by the FDA audit.
EIR is Enterprise Inspection Report, which stands for EstablishmentInspectionReport.
When the FDA audit officer in the enterprise after the completion of the audit, the preparation of the EIR report, submitted to the FDA department and the person in charge of the audit, review and approval of the final supervisory department director to write a letter of information to the person in charge of the enterprise, will be its EIR report and its letter of information issued together. This letter will be signed by the supervisor and the EIR report will be signed by the auditing officer, and eventually mailed to the person in charge of the enterprise in paper form.
The EIR report will include a general summary, a basic introduction to the company and its products, information about the personnel involved in the review and their responsibilities, the content of the review and the documents involved, and the conclusions of the review. If no observations were made, it will be noted in the general summary and conclusions that no FDA 483 was made, and if so, it will be noted in the summary and conclusions, and a copy of the FDA 483 form will be attached as an exhibit to the EIR report.
Expanded Information:
The U.S. Food and Drug Administration (Food and Drug Administration) is referred to as FDA, which is one of the U.S. government's executive agencies within the Department of Health and Human Services (DHHS) and the Department of Public **** Health (PHS).
As a scientific regulatory agency, the FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical devices, and radiological products produced in or imported into the United States. It was one of the first federal agencies to have consumer protection as its primary function.
The agency is relevant to the lives of every U.S. citizen. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries promote and monitor the safety of their country's products by seeking and receiving help from the FDA.
The FDA, which stands for the U.S. Food and Drug Administration, is one of the executive agencies established by the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public **** Health (PHS). As a scientific regulatory agency, FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biologicals, medical devices, and radiological products produced in or imported into the United States.
It was one of the first federal agencies to have consumer protection as its primary function. The agency is relevant to the lives of every American citizen. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries promote and monitor the safety of their own products by seeking and receiving help from the FDA.
Traditionally, FDA approval is not a certification, but rather a registration or enrollment.
The FDA does not issue certificates.
The FDA's drug approval process is rigorous, as they do not conduct their own drug testing, but rather review test results and information provided by pharmaceutical companies, and the program review team consists of more than a dozen pharmacologists, statisticians, scientists and other experts. Conrad passed the FDA's review of its phase II clinical trial for pancreatic cancer in May.
Chinese medicine is widely respected in China, but going international has not been easy. For example, acupuncture, which has been practiced in China for thousands of years, has only gradually gained more recognition and acceptance in the West in recent decades.
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