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Skyline Herbals Private Limited, an OTC drug manufacturer registered to produce toothpaste and other products containing ingredients susceptible to contamination with diethylene glycol (DEG) and ethylene glycol (EG), failed to respond to three separate FDA requests for records issued between November 2022 and December 2022 pursuant to section 704(a)(4) of the FD&C Act. The company did not provide the requested records or information despite confirmed delivery of written communications and a direct telephone conversation with its registered U.S. Agent. This refusal to permit access to and copying of required records constituted a prohibited act under section 301(e) of the FD&C Act, with particular concern given that DEG and EG contamination has caused lethal poisoning incidents in humans globally.