1. The meaning of FDA 483
Hello! FDA (483) refers to: FDA 483 Form (FDA 483 Form), also called Inspectional Observation. It is what the FDA inspector discovered during the on-site inspection of the quality system of the pharmaceutical company in accordance with cGMP specifications. Summary list of non-compliance with cGMP.
2. FDA 483 defects
The U.S. Food and Drug Administration (FDA) performs its supervisory duties and has thousands of different forms, each of which manages different matters. , in order to distinguish different forms, FDA assigns different codes to different forms.
Among them, if the US FDA inspection officers find non-conformities (483 defects) after conducting factory inspections, and if the factory cannot complete the rectifications within the extended period until the FDA deems them compliant, the FDA inspection officers will Non-compliance items are written on Form 483.
Companies that receive Form 483 need to make rectifications within a time limit. In principle, the upper limit is only 15 days. If they fail to complete rectifications within the time limit and become compliant, the U.S. FDA may issue an order for not meeting the quality system requirements. Take further action. Including:
If the product is a food company, a second factory inspection may be organized, and the FDA will charge an hourly fee; for products that have been marketed in the United States, a meeting will be organized between the company and FDA officials with professional backgrounds in the corresponding products. , determine the company's subsequent rectification plan, or determine the implementation plan for recalling products; add the company to the blacklist and issue warning letters based on the reasons why the company does not meet GMP/cGMP requirements. If you want to know more about the latest FDA regulations or seek FDA certification/registration, you can contact @Registrar CorpFDA’s official website for answers to 483