True Chemical Solutions, LLC – FDA Warning Letter, Oct 5, 2021

This FDA Warning Letter, dated September 29, 2021, addresses a firm registered as a manufacturer of OTC drug products, specifically "HAPPY HANDS Hand Sanitizer Topical Gel with Moisturizing Solution." The FDA initiated an electronic request for records and information on November 10, 2020, under section 704(a)(4) of the FD&C Act, which went unanswered. Subsequent telephone calls and a certified mail follow-up on May 4, 2021, also received no response, constituting a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) for refusing access to required records.

The FDA noted a lack of quality assurance information for the drugs manufactured, especially concerning the firm's additional involvement in pipeline operations and fracking, which could pose contamination risks. The letter requires a response within 48 hours to confirm/update registration/drug listing status and indicate intent to provide the requested records. If drug manufacturing has ceased, the firm must delist products and deregister the facility. Failure to respond may result in the firm's hand sanitizer products being added to the FDA's "hand sanitizers consumers should not use" list. The FDA may also conduct an inspection to verify information and assess compliance.