FDA Inspection Reports Demystified: A Comprehensive Anatomy of Form 483, EIR & Warning Letters!

You would never realize how much critical information is hidden behind FDA inspection reports! As a cross-border seller in Taiwan, understanding the FDA's Form 483, EIR, and Warning Letter may determine whether or not your products can successfully enter the U.S. market.

I. The Truth About FDA Form 483 Revealed

FDA Form 483, also known as the "Field Observation Report", 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 "report card" that directly reflects whether your business meets U.S. standards!

II. Serious Consequences of the 483 Deficiency

What's most striking is that companies that receive a Form 483 have only 15 days to rectify the situation! If the deadline is not met, the FDA may take further action, including:

• 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 warning letter.

C. Explanation of Factory Investigation Report (EIR)

What's even more outrageous is that in addition to the Form 483, the inspector is required to prepare an EIR (Factory Investigation Report). This report is completed within 30 business days and is reviewed by the FDA office and ultimately identified as having one of the following three statuses:

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

IV. Seriousness of Warning Letters

If a serious deficiency is found during the inspection and the response to the Form 483 is determined to be inadequate, FDA will issue a warning letter. Companies are required to respond within 15 business days, detailing solutions and preventive measures. Worst of all, these warning letters are usually published on the FDA's official website, which is a serious blow to a company's image!

For more information on FDA registration/certification or if you need professional assistance with FDA compliance issues, please contact our professional team!

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#FDA Inspection # Cross-border E-commerce # Taiwan Sellers #FDA Compliance # Form 483 # Warning Letter # Cross-border Going Overseas # Amazon Sellers # Global Open Store # Brand Protection