FDA (483) refers to: FDA 483 Form (FDA 483 Form), also known as on-site observation report (Inspectional Observation), it is the FDA inspector according to the cGMP regulations, the quality system of the pharmaceutical company's on-site inspection process found to be non-compliance with cGMP place listed on the summary list.
Second, the FDA 483 defects of the U.S. Food and Drug Administration (FDA) to fulfill its supervisory responsibilities, its factory inspection officials in the factory inspection, such as found non-conformity (483 defects), and the factory can not be extended period of time to complete the rectification to the FDA qualified standards, the FDA inspection officials will not comply with the items counted in the Form 483. Enterprises that receive Form 483 need to be rectified within the deadline, in principle, the deadline [only 15 days], if not corrected within the deadline, then the U.S. FDA may not meet the quality system requirements, 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., will organize enterprises and the corresponding product professional background of the FDA officials meeting to determine the enterprise's subsequent rectification plan, or to determine the implementation of the plan for the recall of the product; may be non-compliance with the requirements of the enterprise GMP / cGMP reasons, the enterprise will be added to the black list, the issuance of a [warning letter] and so on. Warning Letter], etc.
Third, factory investigation report (EIR) EIR that is, Establishment Investigation Report factory investigation report, inspection officials in addition to Form 483, but also need to make EIR. EIR will be completed within 30 working days, and then submitted to the FDA regional office or central office responsible person for the inspection, the inspection will be identified as the following several states:
2️⃣ VAI: Voluntary Action Indicated - Voluntary Action Indicated - Non-compliant items are found, but no official action is required. All actions of the company are voluntary.
3️⃣ OAI: Official Action Indicated - official action required - non-compliant item found, further regulatory action required (e.g. warning letter)
Warning Letter) During the inspection process, if serious deficiencies are found and the response to Form 483 is determined to be inadequate, the U.S. Food and Drug Administration (FDA) will issue a warning letter. Companies are required to respond within 15 business days, detailing how they will address the deficiencies and take steps to prevent their recurrence. Warning letters are usually published on the official FDA website.
EN 
ZH_TW 
ZH