Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3009562273.
Violations0
Issue DateJun 14, 2024
Product TypeDevices
StatusOpen
Letter Details
Firm
AG Essence, Inc.
Location
United States
FEI Number
3009562273
Country
United States
Issue Date
June 14, 2024
Issuing Office
Center for Devices and Radiological Health
Product Type
Devices
Status
Open
Summary
Based on limited metadata, AG Essence, Inc. received an FDA Warning Letter on June 14, 2024, regarding medical devices manufactured or distributed by the company. Without access to the full letter text or specific subject line, the exact nature of the violations cannot be determined from the available information. The warning falls under FDA's device regulatory authority, though the specific issuing office is not identified in this metadata summary.
AG Essence, Inc. FDA Warning Letter, June 14, 2024