FDA inspection report of the three major types of full analysis! Taiwan sellers must read

For those of you who are in regular contact with cross-border e-commerce, beware! The FDA Form 483, EIR and Warning Letter are three documents that can make the difference between life and death for your business! As a Taiwanese cross-border seller preparing to enter the U.S. market, you need to know these key facts.

I. FDA Form 483: Field Observation Report

FDA Form 483, also known as Inspectional Observation, is a list of nonconformities found by FDA inspectors during on-site inspections of a pharmaceutical company's quality system in accordance with cGMP regulations. It's like a "problem list" that directly points out where your product or process does not meet U.S. standards!

II. FDA 483 Deficiencies: 15-Day Rectification Period

What's most shocking is that when the FDA inspection officer finds noncompliance and the factory is unable to complete the corrections within the extended period, these problems will be recorded in the Form 483. Upon receipt of a Form 483, a company has only 15 days to make corrections! If corrections are not made within the time period, the FDA may take further action:

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

EIR Factory Survey Report: Three Categories of Results

In addition to the Form 483, inspecting officials are required to prepare an EIR (Establishment Investigation Report). This report is usually completed within 30 business days and is reviewed by the FDA office and categorized into one of three statuses:

1. NAI: No action required - no non-compliant items were found during the inspection, which is the most desirable outcome
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. Warning letters: the most severe penalties

When a serious deficiency is identified during an inspection and the response to the Form 483 is determined to be inadequate, FDA will issue a warning letter. Firms are required to respond within 15 business days, detailing solutions and measures to prevent recurrence.

For example, if the product is a food company, it will be possible to organize a second factory inspection, the FDA will charge by the hour; for products that have already been marketed in the United States, it will organize a meeting between the company and the FDA officials with the appropriate professional background of the product, to determine the company's subsequent corrective action plan, or to determine the implementation plan for the recall of the product.

It is especially important to note that warning letters are publicized on the FDA's official website, which can have an immeasurable negative impact on brand image and market trust.

For Taiwanese cross-border e-commerce sellers planning to enter the U.S. market, it is important to understand these FDA inspection reports, which are directly related to whether your products can be successfully cleared and sold in the U.S. market.

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