FDA Inspection Report: Analysis of Three Major Types! A must-read guide for Taiwan cross-border sellers
FDA Inspection Report Confusion Solved in Three Words: Understanding Form 483, Mastering EIR Reporting, and Avoiding the Risk of Warning Letters. This knowledge is crucial for Taiwan's cross-border brands preparing to enter the U.S. market!
I. FDA Form 483: List of Issues
Did you know that FDA Form 483 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 "checklist of problems" that points out where your organization is not complying with U.S. standards!
II. Serious Consequences of FDA 483 Deficiencies
When the U.S. Food and Drug Administration (FDA) carries out its oversight responsibilities, plant inspection officials find nonconformities (483 deficiencies) that are recorded on Form 483 if the plant is unable to complete corrective actions to FDA conformity standards within the extended period of time.
Did you notice? After receiving a Form 483, a company has only 15 days to make corrections! Failure to do so in such a short period of time may result in further action by the FDA:
- Food companies may organize secondary factory inspections and may also charge by the hour.
- For marketed products, the FDA will organize professional meetings to determine the corrective action or recall plan.
- Businesses may be blacklisted and receive warning letters for non-compliance with GMP/cGMP requirements
III. EIR Factory Survey Report: Three Findings
The EIR, or Establishment Investigation Report, is an important document that inspection officials are required to produce in addition to the Form 483. This report is usually completed within 30 business days and after review by the FDA office, it will be categorized into the following three statuses:
1️⃣ NAI: No Action Indicated - No action required (no violations found during inspection)
2️⃣ VAI: Voluntary Action Indicated - Voluntary Action (found non-compliant items, but no official action required)
3️⃣ OAI: Official Action Indicated - Official Action Required (Further Regulatory Action Required if Breach Found)
IV. Warning letters: the most severe penalties
During the inspection process, if serious deficiencies are found 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.
Most notably, warning letters are publicized on the FDA's official website, which can have an immeasurable negative impact on brand image and market trust. Once a warning letter is received, a company's image in the U.S. market can be severely impacted, even affecting future sales and partnership opportunities.
For Taiwanese e-commerce entrepreneurs planning to enter the U.S. market, it's 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. If you want to ensure that your products are FDA compliant and avoid these potential risks, take action now!
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