Peter Schiff Enterprises – FDA Warning Letter, Dec 31, 2025

The FDA issued a warning letter to Peter Schiff Enterprises following an inspection from December 29 to December 31, 2025, at its Cookeville, Tennessee facility. The inspection focused on the firm"s cardiac electrode pads and fibrillators. The FDA determined that the company is in violation of the Federal Food, Drug, and Cosmetic Act for marketing devices without the necessary regulatory clearances or approvals. Specifically, the firm"s fibrillators were significantly modified from their original designs—including changes to battery types and shifts from analog to digital systems—without the required notifications to the FDA.

Furthermore, the inspection revealed systemic failures in the company"s quality management system. Major issues included a lack of purchasing controls, such as the use of household cleaning agents and non-medical grade materials in production. The firm also failed to establish design controls, maintain device history records, or conduct internal audits and management reviews, some of which are repeat violations from inspections dating back to 2011. Additionally, the company failed to implement procedures for medical device reporting and did not include required Unique Device Identifiers (UDI) on its product labeling.

To address these violations, Peter Schiff Enterprises must submit a written response within 15 business days outlining its corrective action plan. The FDA requires the company to hire an independent consultant to audit its manufacturing and quality systems, with certifications of these audits and corrections due annually through February 2029. The company was also notified that all future corrective actions must align with the current Quality Management System Regulation (QMSR) standards.