FDA Compliance Must Read: A Complete Guide to Form 483, EIRs and Warning Letters

With these three tricks, I have successfully assisted many Taiwanese companies to pass FDA inspections! As a cross-border brand owner, understanding the FDA inspection report system is the basic skill to enter the US market. Today, I will analyze the three key documents of FDA: Form 483, EIR and Warning Letter.

I. FDA Form 483: Field Observation Report

FDA Form 483, also known as the "Field Observation Report," is a list of nonconformities found by an FDA inspector during an inspection of a pharmaceutical company's quality system in accordance with cGMP regulations. It is the first warning that the FDA sends to a company.

For example, an FDA inspector may find:

• Non-compliance of production process
• Inadequate quality control
• Substandard record keeping

What's even more remarkable is that the FDA has given companies the opportunity to make corrections. However, it is important to note that the deadline for correction is only 15 days! If corrective action is not completed within the deadline, the FDA may take further action, including a second factory inspection, product recall, or even blacklist the company.

Factory Investigation Report (EIR): Comprehensive Assessment

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.

EIR is categorized into three different states:

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

After all, the goal of a business should be to achieve an NAI or at least a VAI rating to avoid more serious consequences.

Warning Letter: Serious warning

If serious deficiencies are found during the inspection process and the business'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.

Companies are required to respond to the warning letters within 15 business days, detailing solutions and precautions. The worst part is that these warning letters are usually published on the FDA's official website, which can have a serious impact on a company's reputation!

For Taiwan cross-border exporters planning to enter the U.S. market, it is important to understand the differences in these FDA inspection documents and the strategies for dealing with them. Advance preparation and strict compliance with FDA regulations will ensure the smooth entry of your products into the U.S. market!

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