HealthMEDS Inc. – FDA Warning Letter, Oct 12, 2021

This FDA Warning Letter, dated September 29, 2021, was issued to HealthMEDS Inc., a registered manufacturer of over-the-counter (OTC) drug products, specifically ProClean-Pure Atomizer Mist 5 mL. The letter details the firm's failure to respond to multiple FDA requests for records and information under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA initially sent an electronic request on February 1, 2021, which went unanswered, as did numerous follow-up telephone calls. A certified mail request was sent on May 6, 2021, which also received no response. The FDA states that refusing to permit access to or copying of records as required by section 704(a) is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)).

The Agency emphasized that due to the firm's non-response, there is no indication of the level of quality assurance for drugs manufactured at their facility, especially in the context of numerous hand sanitizer recalls during the COVID-19 public health emergency.

HealthMEDS Inc. is required to respond within 48 hours to confirm or update their registration and/or drug listing status and indicate whether they will provide the requested records. If