Babikian Healthcare Products CJSC – FDA Warning Letter, Aug 12, 2025

Babikian Healthcare Products CJSC, an Armenian manufacturer of over-the-counter (OTC) drugs, received a warning letter from the FDA on September 21, 2026, following a review of records requested in August 2025. The review identified significant failures to comply with Current Good Manufacturing Practice (CGMP) standards under the Federal Food, Drug, and Cosmetic Act, leading the FDA to categorize the company’s products as unsafe for the U.S. market. The primary violations involved a systemic lack of quality oversight. Specifically, the firm failed to test incoming raw materials to verify their identity and relied on unverified supplier documents. Furthermore, the company released finished drug products for distribution without performing essential laboratory tests to confirm their strength, identity, or safety from microbial contamination. The FDA also found that the firm’s Quality Control Unit failed to establish proper production procedures, maintain complete manufacturing records, or provide stability data to justify expiration dates. Additionally, a second facility was found to be operating without the required FDA registration. In response to these findings, the FDA placed the company’s products on an import alert in June 2026. The firm is now required to hire an independent consultant to conduct a comprehensive audit of their operations and implement corrective actions. Babikian Healthcare Products must submit a detailed plan to the FDA within 15 business days outlining how they will address these deficiencies and ensure future compliance.