FDA WARNING_LETTER - RESPILON Production S.R.O. - May 02, 2025

On April 20, 2026, the FDA issued a warning letter to Respilon Production S.R.O., located in Brno, Czech Republic, following a review of records requested in May 2025. The agency determined that the facility’s over-the-counter drug manufacturing processes failed to comply with Current Good Manufacturing Practice (CGMP) regulations under the Federal Food, Drug, and Cosmetic Act. Major violations included the failure to conduct identity testing on raw material components and neglecting to screen for hazardous contaminants in high-risk ingredients. Additionally, the firm lacked a stability testing program to support product expiration dates and failed to validate its manufacturing processes and laboratory test methods. The FDA also noted that the company did not perform adequate microbial testing and maintained incomplete laboratory records that lacked specific data for active ingredients. Consequently, the products are considered adulterated. The FDA has directed Respilon to respond within 15 working days with a detailed plan for corrective actions and strongly recommends the engagement of a qualified consultant to conduct a comprehensive audit of their manufacturing systems. Failure to address these concerns may result in the FDA refusing entry of the company’s products into the United States or withholding approval for future drug applications.