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HealthMEDS Inc., a manufacturer of over-the-counter drug products including ProClean-Pure Atomizer Mist, failed to respond to FDA records requests issued on February 1, 2021, and a follow-up certified letter sent May 6, 2021, in violation of section 704(a) of the Federal Food, Drug, and Cosmetic Act. The company did not provide requested records or information despite multiple electronic and telephone communications from the Agency, constituting a prohibited act under section 301(e) of the FD&C Act. The FDA's request was part of a broader quality assessment initiative for hand sanitizer products, following numerous recalls due to quality defects ranging from drug substance substitution to subpotency during the COVID-19 public health emergency.