Why are FDA site inspection deficiencies called 483 deficiencies?

The U.S. Food and Drug Administration (FDA) carries out its oversight responsibilities with thousands of different forms, each of which governs different matters, and in order to distinguish between the different forms, the FDA assigns different codes to different forms. Among them, the U.S. FDA factory inspection officer after the factory inspection, if found a nonconformity, such as the factory can not be completed in the extended period of rectification to the FDA that comply with the FDA, the FDA inspection officer will be nonconformity will be written into the Form 483.

Enterprises that receive Form 483 need to rectify within the deadline, in principle, the deadline is only 15 days, such as failing to complete the rectification of the deadline for compliance, then the U.S. FDA may not meet the requirements of the quality system, to take further action. Including, if the product is a food company, will likely organize a second factory inspection, the FDA will charge by the hour; for products already listed in the U.S., the organization of the enterprise and the corresponding product professional background of the FDA officials of the meeting, to determine the enterprise's subsequent rectification plan, or to determine the implementation of the plan to recall the product; to the enterprise does not meet the requirements of the GMP / cGMP reasons, will be added to the enterprise's blacklist, as well as the issuance of warning letters, etc. Click here to learn about FDA regulatory requirements for free