True Chemical Solutions, LLC

Warning LetterOpen

Mr. Travis Pitcock Chief Executive Officer True Chemical Solutions, LLC 6215 W. County Road 112 Midland , TX 79706 United StatesFEI 3016866715Issued Sep 29, 2021Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016866715.

Violations0

Issue DateSep 29, 2021

Product TypeOther

StatusOpen

Letter Details

Firm: True Chemical Solutions, LLC
Location: Mr. Travis Pitcock Chief Executive Officer True Chemical Solutions, LLC 6215 W. County Road 112 Midland , TX 79706 United States
FEI Number: 3016866715
Country: United States
Issue Date: September 29, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

True Chemical Solutions, LLC manufactured OTC hand sanitizer products but failed to respond to FDA records requests sent via electronic communication in November 2020 and certified mail in May 2021, violating section 301(e) of the Federal Food, Drug, and Cosmetic Act. The company's non-compliance prevented FDA from assessing quality assurance measures at the facility during a period when numerous hand sanitizer products were being recalled due to quality defects including drug substance substitution and subpotency. The FDA's enforcement action was prompted by heightened regulatory scrutiny of hand sanitizer manufacturers following the COVID-19 public health emergency.

True Chemical Solutions, LLC FDA Warning Letter, September 29, 2021