Warning Letter — Chirp Innovations, LLC
The FDA issued a Warning Letter to Chirp Innovations, LLC on October 2, 2026, following an evaluation by the Center for Devices and Radiological Health (CDRH).
This affects Chirp Innovations, LLC and regulatory/quality departments responsible for ensuring medical device compliance and market authorization.
The issuance of a Warning Letter by CDRH typically indicates significant deviations from the Federal Food, Drug, and Cosmetic Act, such as marketing a device without required clearance or approval, or violating Quality System Regulations. While the specific violations are not detailed in the provided excerpt, such actions often lead to forced market withdrawal or import alerts if not remediated.
Review current product portfolios for any devices marketed without valid 510(k) clearance or PMA approval. Regulatory teams should ensure that all marketed claims align strictly with cleared indications for use to avoid misbranding or adulteration charges.
FDA Warning Letter issued to: Chirp Innovations, LLC. 10/02/2026 — Center for Devices and Radiological Health. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chirp-innovations-llc-731847-10022026
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