Chirp Innovations, LLC – FDA Warning Letter, Nov 21, 2025

Chirp Innovations, LLC, located in Lehi, Utah, received an FDA Warning Letter following an inspection conducted from November 18 to 21, 2025. The FDA determined that the company’s Chirp Halo Wireless Muscle Stimulator is adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act due to significant regulatory failures. Key violations include the failure to establish a comprehensive quality management system, specifically lacking documented procedures for management reviews, quality audits, design controls, and purchasing controls. Additionally, the company failed to maintain adequate systems for handling consumer complaints and implementing corrective and preventive actions. A major concern involves unapproved marketing; the device was cleared only for muscle pain related to exercise or housework, yet the company promoted it for menstrual pain relief. This unauthorized change in intended use requires new regulatory clearance or approval. Furthermore, the firm failed to establish required Medical Device Reporting procedures for evaluating and reporting adverse events to the FDA. While Chirp Innovations submitted several responses between late 2025 and mid-2026, the FDA found them insufficient as the firm failed to provide the actual written procedures for review. The company must provide a written response within 15 business days detailing the specific corrective steps taken and a timeline for future compliance. Failure to address these issues may result in regulatory actions, including product seizures or financial penalties. All future corrective measures must comply with the updated Quality Management System Regulation that became effective in early 2026.