Smiths Medical ASD Inc.

Warning LetterOpen

United StatesFEI 1217052Issued Oct 1, 2021Center for Devices and Radiological Health

View Letter

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 1217052.

Violations0

Issue DateOct 1, 2021

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Smiths Medical ASD Inc.
Location: United States
FEI Number: 1217052
Country: United States
Issue Date: October 01, 2021
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Based on limited metadata, Smiths Medical ASD Inc. received an FDA Warning Letter on October 1, 2021, regarding compliance issues with 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 details remain unknown. This summary is preliminary and should be supplemented with the complete warning letter for comprehensive regulatory analysis.

Smiths Medical ASD Inc. FDA Warning Letter, October 1, 2021