80% Full analysis of FDA inspection reports that cross-border sellers don't know!

Any Taiwan cross-border sellers who want to enter the U.S. market, to give you a trick: do not worry, do not need to panic, as long as the understanding of the FDA's three major inspection report documents, you can easily respond to the FDA inspection! Today we will analyze what is Form 483, EIR and Warning Letter.

I. FDA Form 483: Field Observation Report

FDA Form 483, also known as the Inspectional Observation, is a list of nonconformities found by an FDA inspector during an on-site inspection of a pharmaceutical company's quality system in accordance with cGMP regulations. Simply put, it is a "problem list" that the FDA inspector gives to your company.

II. FDA 483 Deficiencies: A Strict 15-Day Correction Period

You'd never guess that when FDA inspection officials find noncompliance issues and the factory is unable to complete the corrective action within the extended period, these issues will be recorded in the Form 483. The most eye-opening part is that companies that receive a Form 483 have only 15 days to rectify the problem!

Failure to complete the correction 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.
• Worse still, companies may be blacklisted and receive warning letters for non-compliance with GMP/cGMP requirements.

EIR Factory Survey Report: Three Categories of Results

The EIR is the Establishment Investigation Report, which is prepared by the inspecting official in addition to the Form 483. This report will be completed within 30 working days, and then inspected by the FDA office staff, and will eventually be recognized as one of the following 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: Public Sanctions

During the inspection process, if a serious deficiency is found and the response to the Form 483 is determined to be inadequate, FDA will issue a warning letter. The company must respond within 15 business days, detailing how it will address the deficiency and take steps to prevent its recurrence.

The biggest problem is that these warning letters are publicized on the FDA's official website, which has 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 Taiwan-based cross-border e-commerce sellers planning to enter the US 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 US market. If you want to ensure that your products are FDA compliant and avoid these potential risks, take action now!

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# Cross-border E-commerce #DA483 # Taiwan Sellers # Brand Protection # Amazon Global Store # Compliance # Warning Letter # International E-commerce # Cross-border Going to Sea