HTO Nevada, Inc. dba Kirkman

Warning LetterOpen

Mr. Eric Jon Gripentrog Chief Executive Officer HTO Nevada, Inc. dba Kirkman 6400 Rosewood Street Lake Oswego , OR 97035-5392 United StatesFEI 3004268965Issued Jan 27, 2026Center 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 3004268965.

Violations4

Issue DateJan 27, 2026

Product TypeDrugs

StatusOpen

Letter Details

Firm: HTO Nevada, Inc. dba Kirkman
Location: Mr. Eric Jon Gripentrog Chief Executive Officer HTO Nevada, Inc. dba Kirkman 6400 Rosewood Street Lake Oswego , OR 97035-5392 United States
FEI Number: 3004268965
Country: United States
Issue Date: January 27, 2026
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

HTO Nevada, Inc. dba Kirkman, an over-the-counter drug manufacturer, failed to maintain Current Good Manufacturing Practice (CGMP) standards for finished pharmaceuticals, resulting in adulterated drug products. During an August 2025 inspection, the FDA identified critical failures in the quality control unit's oversight, including inadequate change control procedures that allowed reformulated drug products to be released and distributed with inaccurate labeling after API substitution. The company's September 2025 response was deemed inadequate because it only stated the firm would cease drug manufacturing without providing corrective and preventive actions or committing to market removal of affected products.

HTO Nevada, Inc. dba Kirkman FDA Warning Letter, January 27, 2026