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 1037230.
Violations0
Issue DateApr 4, 2023
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Sea-Long Medical Systems, LLC
Location
United States
FEI Number
1037230
Country
United States
Issue Date
April 04, 2023
Issuing Office
Division of Medical Device and Radiological Health Operations West
Product Type
Medical Devices
Status
Open
Summary
Based on limited metadata, this FDA Warning Letter issued to Sea-Long Medical Systems, LLC on April 4, 2023, concerns violations related to medical devices. 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 medical device regulatory authority, though the specific issuing office and violation count are not specified in the metadata provided.
Sea-Long Medical Systems, LLC FDA Warning Letter, April 4, 2023