Warning Letter — Balkanica LLC
The FDA issued a Warning Letter to Balkanica LLC following an inspection by the Office of Inspections and Investigations. The letter serves as formal notification of regulatory violations identified during the agency's oversight activities.
This affects Balkanica LLC, its operational management, and quality control departments responsible for facility compliance.
The issuance of a Warning Letter indicates that the FDA found significant violations of regulatory requirements during its inspection. Failure to provide an adequate response or implement corrective actions may lead to further enforcement measures, such as seizure or injunction. The involvement of the Office of Inspections and Investigations suggests the findings were substantiated through direct observation of facility operations.
Firms should immediately review current Good Manufacturing Practice (cGMP) compliance at the facility level. Quality teams should conduct a gap analysis of existing sanitation and production logs to ensure they meet federal standards before further regulatory scrutiny.
FDA Warning Letter issued to: Balkanica LLC. 06/29/2026 — Office of Inspections and Investigations. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/balkanica-llc-732478-06292026
Open in openFDA / FDA.gov