Dyno Manufacturing, Inc.

Warning LetterOpen

Ms. Jennifer A. Boofer General Manager/QA Manager Dyno Manufacturing, Inc. 2 Fox Industrial Dr. Madison , IL 62060-1155 United StatesFEI 3017219182Issued Apr 9, 2025Center 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 3017219182.

Violations5

Issue DateApr 9, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Dyno Manufacturing, Inc.
Location: Ms. Jennifer A. Boofer General Manager/QA Manager Dyno Manufacturing, Inc. 2 Fox Industrial Dr. Madison , IL 62060-1155 United States
FEI Number: 3017219182
Country: United States
Issue Date: April 09, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Dyno Manufacturing, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter hand sanitizer and antibacterial hand soap products. The FDA inspection found that the company failed to conduct identity testing on incoming raw material components (such as ethanol, glycerin, and propylene glycol) and instead relied solely on suppliers' certificates of analysis without validating their reliability. The firm did not adequately test high-risk components for contamination with diethylene glycol (DEG) or ethylene glycol (EG) before using them in drug manufacturing, resulting in adulterated drug products that did not meet required manufacturing standards.

Dyno Manufacturing, Inc. FDA Warning Letter, April 9, 2025