Warning letterPosted June 23, 2026

FDA warning letter to Great Enterprise - Group - Inc.

Foreign Supplier Verification Program (FSVP)

FDA's record ↗

FDA posted a warning letter to Great Enterprise - Group - Inc. on June 23, 2026; the letter is dated April 17, 2026. Subject: Foreign Supplier Verification Program (FSVP). Issuing office: Office of Inspections and Investigations.

On the record

Company
Great Enterprise - Group - Inc.
Subject
Foreign Supplier Verification Program (FSVP)
Issuing office
Office of Inspections and Investigations
Letter dated
2026-04-17
Posted by FDA
2026-06-23
Source
FDA warning letters ↗

CFR cited

The record cites 1 section of 21 CFR Parts 1 and 113.

The full record

An account shows the violations FDA described and each CFR section it cited.

What a warning letter is

A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.

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