GTP International Corp

Your firm is registered with the United States Food and Drug Administration (FDA or Agency) as a manufacturer of over-the-counter (OTC) drug products; specifically, products including (b)(4) Hand Sanitizer. On August 16, 2022, the FDA sent an electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file. A second email request was sent on August 31, 2022. FDA attempted to contact your firm by phone on October 24, 2022, and left a voice message requesting a response by October 31, 2022. The Agency sent a follow-up written request for such records and other information via certified return-receipt mail that was delivered to the physical address provided in your registration file on November 22, 2022. These requests went unanswered. On August 1, 2023, we contacted you by phone, during which you did not acknowledge FDA’s previous attempts to contact you, but agreed to respond to our request for records and other information by August 2, 2023. However, you failed to respond to these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request for records and follow-up communication included a sufficient and clear description of the records sought.

It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a).

Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts,1 we have no indication of the level of quality assurance for drugs registered as manufactured at your facility.

Respond to this letter within 48 hours to confirm or update your registration and/or drug listing status and indicate whether you will respond to the request for records and other information. If you are no longer manufacturing drugs, delist all the drugs previously listed with FDA, using the last lot expiration date as the marketing end date of the product, and deregister your facility accordingly.

The Agency may conduct an inspection to verify information provided and/or to evaluate the compliance of your manufacturing operations.

Continued non-response regarding questions of the quality assurance of the drugs manufactured at your facility may lead to inclusion on the Agency’s list of hand sanitizers consumers should not use, at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use.

You may provide additional information for our consideration as we continue to assess your activities and practices.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov.

Identify your response with FEI 3012495223 and ATTN: Joel Hustedt.