GTP International Corp

Warning LetterOpen

Mr. Vu Tran President GTP International Corp 3677 W. Emporium Circle Mesquite , TX 75150 United StatesFEI 3012495223Issued Aug 4, 2023Center for Drug Evaluation and Research | CDER

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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 3012495223.

Violations1

Issue DateAug 4, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: GTP International Corp
Location: Mr. Vu Tran President GTP International Corp 3677 W. Emporium Circle Mesquite , TX 75150 United States
FEI Number: 3012495223
Country: United States
Issue Date: August 04, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

GTP International Corp, a manufacturer of over-the-counter hand sanitizer products, failed to provide access to and copying of records requested by the FDA pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. Despite multiple contact attempts between August 2022 and August 2023—including two email requests, a phone call with a voicemail, and certified mail—the company did not respond to or provide the requested records and information. This refusal constituted a prohibited act under section 301(e) of the FD&C Act, leaving the FDA without information to assess the quality assurance of drugs manufactured at the facility. The FDA demanded a response within 48 hours confirming registration and drug listing status and indicating whether the company would comply with the records request.

GTP International Corp FDA Warning Letter, August 4, 2023