Warning Letter — Peter Schiff Enterprises
The FDA issued a Warning Letter to Peter Schiff Enterprises following an inspection by the Center for Devices and Radiological Health (CDRH).
This affects Peter Schiff Enterprises and personnel responsible for regulatory compliance, quality assurance, and device manufacturing within the organization.
A Warning Letter from the CDRH indicates that the FDA has identified significant violations of regulatory requirements. This may lead to restricted device distribution, withholding of product approvals, or further enforcement actions if the cited deficiencies are not remediated to the agency's satisfaction.
Review current quality management systems for compliance with CDRH requirements and ensure all device-related operations are supported by appropriate regulatory filings and documentation. Facilities should conduct an internal audit of manufacturing and reporting procedures to address potential gaps identified in recent CDRH inspections.
FDA Warning Letter issued to: Peter Schiff Enterprises. 08/26/2026 — Center for Devices and Radiological Health. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peter-schiff-enterprises-727888-08262026
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