Taiwan cross-border sellers must see! FDA's three major inspection reports are fully analyzed!

FDA Inspection Report: What is a Form 483, EIR, Warning Letter? It's amazing how these three documents can have such a huge impact on cross-border exporters! As a Taiwanese manufacturer, you need to know these key facts to safely enter the U.S. market.

I. Deciphering FDA Form 483

What is FDA Form 483? It is a list of nonconformities found during an on-site inspection of a pharmaceutical company's quality system by an FDA inspector according to cGMP regulations. Simply put, it is a "problem list" that the FDA inspector gives to your company.

II. Serious Consequences of the 483 Deficiency

I really find it hard to believe that many cross-border brand owners are not aware of the seriousness of FDA 483! When FDA inspection officials find nonconformities and the factory is unable to rectify them in a timely manner, these issues will be recorded in Form 483.

Upon receipt of Form 483, companies have as little as 15 days to complete the corrective action or the FDA may take further action:

• If you are a food company, you may face a second factory inspection and the FDA charges you by the hour.
• For products already marketed in the U.S., the FDA organizes meetings to determine corrective action or recall plans.
• In the worst case scenario, companies may be blacklisted and receive warning letters for non-compliance with GMP/cGMP requirements

C. EIR Factory Survey Report Details

In addition to the Form 483, there is another important document called the EIR (Establishment Investigation Report). This report is usually completed within 30 business days and is reviewed by the FDA office and categorized into the following three 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 take action - further regulatory measures needed if non-compliant projects are found

IV. Serious Impact of Warning Letters

Warning Letters are a severe disciplinary measure by the FDA. When an inspection reveals serious deficiencies and the response to the Form 483 is inadequate, the FDA will issue a warning letter. Companies must respond within 15 business days, detailing solutions and measures to prevent recurrence.

What's even cooler is that these warning letters are publicized on the FDA's official website, which has an immeasurable negative impact on brand image and market trust.

For Taiwan cross-border e-commerce sellers planning to enter the U.S. market, it is important to understand the significance of these FDA inspection reports and the strategies to deal with them, as it directly relates to whether your products can be successfully cleared and sold in the U.S. market.

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# Cross-border E-commerce #DA483 # Taiwan Sellers # Brand Protection # Amazon Global Store # Compliance # Warning Letter # International E-commerce # Cross-border Going to Sea