FDA WARNING_LETTER - GTP International Corp - August 08, 2023

This FDA Warning Letter, dated August 4, 2023, addresses a firm registered as an OTC drug product manufacturer, specifically of (b)(4) Hand Sanitizer. The FDA initiated an electronic request for records and information on August 16, 2022, under section 704(a)(4) of the FD&C Act, followed by a second email on August 31, 2022. Subsequent attempts to contact the firm included phone calls on October 24, 2022, and August 1, 2023, and a certified mail request delivered on November 22, 2022. All requests for records went unanswered.

The firm's failure to provide the requested records constitutes a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)), as it refuses to permit access to records required by section 704(a). This non-response prevents the FDA from assessing the quality assurance of drugs manufactured at the facility.

The FDA requires a response within 48 hours to confirm or update registration/drug listing status and to indicate whether the firm will respond to the records request. If drug manufacturing has ceased, the firm must delist all drugs and deregister the facility. Continued non-response regarding drug quality assurance may lead to inclusion on