Updated Guidance on FDA Inspections in 2025: Full Breakdown of Form 483, EIRs and Warning Letters

80%'s cross-border seller made the first wrong step when facing FDA inspection! As a Taiwanese cross-border exporter planning to enter the U.S. market, it is important to understand the FDA's inspection system. In this article, we will analyze the three key FDA documents: Form 483, EIR, and Warning Letter to help you pass the FDA inspection!

I. FDA Form 483: Initial Warning of Noncompliance

FDA Form 483, also known as the "Field Observation Report," is a list of nonconformities found by an FDA inspector during an on-site inspection of a company under cGMP regulations. It is the first warning that the FDA sends to a company.

The biggest problem is that after receiving the Form 483, the company has only 15 days to rectify the problems! With such a short period of time, companies must respond quickly and resolve all issues. If they do not meet the deadline, the FDA may take more severe measures:

• Organize second factory inspection with hourly rate
• Requires recall of products already on the market in the U.S.
• Blacklisting of companies
• Issuance of warning letters

Factory Investigation Report (EIR): A Comprehensive Assessment Report

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

Depending on the severity of the findings, EIRs are categorized into three different statuses:

1. NAI: No action required - no non-compliant items found during inspection
2. VAI: Voluntary Initiative - Non-compliant items found, but no official action required
3. OAI: Officials Need to Act - Further Regulatory Measures Needed if Non-Compliant Projects are Found

The effect is comparable to scoring a company's compliance status, with NAI being the most desirable result and OAI potentially leading to more serious consequences.

Warning Letter: A formal warning of a serious breach.

Now, if the FDA finds serious deficiencies during the inspection process and the company's response to the Form 483 is deemed inadequate, the FDA will issue a warning letter. This is a very serious document that demonstrates the FDA's deep concern about a company's compliance status.

Businesses are required to respond to the warning letter within 15 working days, detailing solutions and preventive measures. Don't ignore these requirements any longer! Warning Letters are usually published on the official FDA website and can have a serious impact on a company's reputation. In some cases, the warning letter may also result in the product being banned from the U.S. market!

For Taiwanese cross-border brands planning to enter the U.S. market, it is important to understand the differences between these FDA inspection documents and their response strategies. Preparing well in advance and strictly complying with FDA regulations will ensure that your products will pass inspection and successfully enter the U.S. market!

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