USHIO Europe B.V.

Warning LetterOpen

NetherlandsIssued Dec 3, 2019

Letter not published by FDA

Source: FDA warning letter records. FDA has not published the text of this letter.

Letter Details

Firm: USHIO Europe B.V.
Location: Netherlands
FEI Number: N/A
Country: Netherlands
Issue Date: December 03, 2019
Issuing Office: N/A
Product Type: Medical Devices
Status: Open

Summary

USHIO Europe B.V., a medical device manufacturer, received an FDA Warning Letter on December 3, 2019, indicating significant regulatory compliance concerns. Due to limited metadata availability, the specific nature of the violations cannot be determined from this record. The warning letter falls under FDA oversight of medical devices, though the issuing office and detailed violation categories are not documented in the available metadata.