U.S. FDA Compliance: Form 483, EIR and Warning Letter Detailed Explanation

Did you know? An FDA inspection report may determine whether your product can enter the U.S. market! For Taiwan cross-border sellers planning to expand their business in North America, it is important to understand the FDA's inspection system. In this article, we'll take a closer look at the three key FDA documents: the Form 483, the EIR, and the Warning Letter.

FDA Form 483: The First Hurdle in Compliance Checks

What is FDA Form 483? It is a list of nonconformities found by an FDA inspector during an on-site inspection of a pharmaceutical company's quality system in accordance with cGMP regulations. This document is a direct reflection of a company's compliance status.

Businesses that have received Form 483 must complete the corrective action within 15 days! This is a very tight time frame. If you do not meet the deadline, the FDA may take more severe measures:

• Food companies may face second factory inspections and the FDA will charge by the hour.
• Products already on the market in the U.S. may need to be recalled
• Businesses may be blacklisted for non-compliance with GMP/cGMP requirements
• You might even get a more serious warning letter.

Factory Investigation Report (EIR): Comprehensive Assessment

Now, in addition to the Form 483, the FDA inspector produces a Factory Investigation Report (EIR). This report is usually completed within 30 business days, reviewed by the FDA office staff, and categorized into three statuses:

1️⃣ NAI: No Action Indicated - No Action Required: No Violations Found During Inspection
2️⃣ VAI: Voluntary Action Indicated - Voluntary Action: a non-compliant item is found, but no official action is required.
3️⃣ OAI: Official Action Indicated - Official action required: non-compliant items found, further regulatory action required

With this EIR, the FDA is able to conduct a more comprehensive assessment of a company's compliance status.

Warning Letter: Red Card Warning for Serious Violations

The most worrisome aspect is the warning letter. When the FDA finds serious deficiencies during an inspection and the business's response to the Form 483 is deemed inadequate, the FDA will issue a warning letter.

Enterprises are required to respond to the warning letter within 15 working days, detailing solutions and preventive measures. I can't tell you how many companies have paid a terrible price for ignoring these requirements! Warning letters are usually publicized on the FDA's official website, which can have a serious impact on a company's reputation.

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

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