FDA import alert

Immediate Consequences of FDA Factory Inspections

Most Chinese manufacturers will pay more attention to the review notice from the US FDA. Of course, some manufacturers do not understand the possible results of the review and do not pay enough attention, resulting in the latter three results.

There are three direct results of FDA factory inspection, namely NAI, VAI and OAI.

Code full name

NAI - No Action Indicated

VAI - Voluntary Action Indicated

OAI - Official Action Indicated

NAI stated that during the FDA factory inspection,no non-compliance was issued in any written form called "483" (since the number of FDA non-conformance report form is 483, FDA will also be abbreviated as "483").

VAI stated that during the FDA factory inspection, the FDA inspector found that the management system of the factory violated the FDA quality system regulations, and then issued a written non-conformance item, or "483". The number of "483" may be 1 or 20 or more. As long as the factory actively rectifies and provides sufficient evidence in accordance with FDA requirements, it will not lead to more consequences.

OAI stated that during the FDA factory review, the FDA reviewer found that the factory management system seriously violated the FDA quality system regulations, or failed to make timely and adequate rectification of VAI in accordance with FDA requirements, and issued a warning letter (Warning Letter). If only a warning letter is issued without Import Alert, the manufacturer products can still be exported, but the warning letter will be published on the FDA official website, which will affect the confidence of American customers in the manufacturer, and measures must be taken to remove it as soon as possible.

1. VAI has not been fully rectified in accordance with FDA requirements and will develop into OAI;

2. OAI will be listed in Import Alert if it fails to respond in a timely manner in accordance with FDA requirements;

3. Entering the Import Alert, the export products of the enterprise will be automatically confiscated (DWPE) when entering the country.

Import Alert removal due to FDA factory inspection usually requires a second factory inspection. In addition to the second factory review, there is an overwhelming amount of evidence to accompany the petition to FDA review. The most efficient processing cycle takes one year from the start of processing to the final completion of Import Alert removal. Of course, there are also huge costs.

In-Tech has helped several Chinese manufacturers successfully lift warning letters and remove import bans. Many domestic manufacturers usually seek the help of law firms when their products cannot be exported, but practice shows that most of the time, the compliance of technical regulations cannot be solved by law firms.