The Big Three of FDA Inspections: Key Differences Between Form 483, EIR, and Warning Letter

FDA Inspection Documents in Three Sentences! For Taiwan cross-border sellers who plan to enter the US market, it is important to understand the FDA's inspection documents. This article will unravel the mysteries of Form 483, EIRs, and warning letters to help you avoid compliance traps!

FDA Form 483: The First Alarm of Noncompliance

What is FDA Form 483? It is a list of nonconformities found by the FDA inspector during an on-site inspection in accordance with cGMP regulations. It's like a "problem list" that tells you what needs to be improved.

The biggest problem is that after receiving the Form 483, enterprises only have 15 days to rectify the situation! If the company fails to complete the rectification within the deadline, the FDA may take more severe measures, including organizing a second factory inspection, requesting a product recall, or even blacklisting the company.

II. Factory Investigation Report (EIR): A Complete Record of Inspections

In addition to the Form 483, the FDA inspector prepares a Factory Investigation Report (EIR). This report is usually completed within 30 business days and is reviewed by the FDA Office of the Inspector General.

Based on the results of the examination, the EIR is categorized into three different states:

• NAI: No action required - no non-compliant items found during inspection
• VAI: Voluntary Initiative - Non-compliant items found, but no official action required
• OAI: Officials need to take action - Serious non-compliant projects found, further regulatory action required

Warning Letter: Formal notification of a serious breach of regulations

And now, some businesses will receive even more serious warning letters. When the FDA finds serious deficiencies during an inspection and a business's response to Form 483 is deemed inadequate, the FDA will issue a warning letter.

Companies are required to respond to the warning letter within 15 business days, detailing how they will address the defect and prevent recurrence. It is important to note that these warning letters are usually made public on the FDA's official website, which can have a serious impact on a company's reputation!

For Taiwanese manufacturers and cross-border e-commerce sellers who are preparing to enter the U.S. market, it is important to understand the differences between these FDA inspection documents and their response strategies. Early planning and strict compliance with FDA regulations will ensure the smooth entry of your products into the U.S. market!

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