Records Refusal Leads To Warning Letter

Take FDA inquiries seriously

Being unresponsive to official FDA requests can lead to serious issues.

A drug manufacturing facility in India received a records request from FDA. After several attempts, the company responded that they did not make the products FDA was inquiring about, which did not match the information provided by the customer. FDA continued to follow up with no reply. This led to a warning letter and an import alert.

From warning letter. “A contract manufacturing agreement provided by the (b)(4) owner and other records show that you are the manufacturer of (b)(4), which was shipped to the United States. These records include your registration file, your certificate of analysis, and a batch production record.”

All products from this company were placed on import alert, which means they may not be imported into the US. Learn more about import alerts.

Remote Regulatory Assessments (RRAs) are different and may be considered voluntary. I’ve heard that participating in voluntary RRA requests helps prioritize FDA inspections, which can lessen the frequency that FDA inspects and reinspects compliant companies. Learn more about RRAs.

This is a shorter Warning Letter Wednesday than normal as I am speaking at the NutraIngredients Weight Management Summit in San Diego and am still processing the passing of AHPA President Michael McGuffin. Michael, you will be missed with a warm, herbal heart.

Read the full Records Refusal Leads To Warning Letter warning letter.

DATE ORIGINALLY POSTED: 2/19/25

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.