# FDA WARNING_LETTER - True Chemical Solutions, LLC - October 05, 2021

Source: https://www.keypedia.com/records/warning_letter/true-chemical-solutions-llc/17506b2f-e198-4bb4-8963-74d9bca75cb6

> FDA WARNING_LETTER for True Chemical Solutions, LLC on October 05, 2021. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: True Chemical Solutions, LLC
- Inspection Date: 2021-10-05
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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.

## Related Officers

- [Director](https://www.keypedia.com/people/francis-godwin/1556d203-d47c-4744-af37-2591a163149e)

Company: https://www.keypedia.com/companies/true-chemical-solutions-llc/33d21e1b-e3e0-4353-a11a-12957ac64c6d

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c