Won Industry Co. LTD

Warning LetterOpen

South KoreaIssued Aug 29, 2019

Letter not published by FDA

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

Letter Details

Firm: Won Industry Co. LTD
Location: South Korea
FEI Number: N/A
Country: South Korea
Issue Date: August 29, 2019
Issuing Office: N/A
Product Type: Medical Devices
Status: Open

Summary

Based on limited metadata without access to the full letter text, this FDA Warning Letter was issued to Won Industry Co. LTD, a medical device manufacturer, on August 29, 2019. While the specific violations cannot be determined from the available information, the letter indicates regulatory concerns significant enough to warrant formal FDA enforcement action against the company's medical device operations. The actual nature and scope of the violations would require review of the complete warning letter to identify the specific manufacturing, labeling, or compliance deficiencies cited by the FDA.