FDA WARNING_LETTER - Siddha Flower Essences - April 29, 2025

The FDA issued a Warning Letter to Siddha Flower Essences, LLC., dba Siddha Remedies, following an inspection of its Oxnard, CA drug manufacturing facility from April 22 to 29, 2025. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering the company"s human and animal drug products adulterated under the Federal Food, Drug, and Cosmetic Act. Key issues include the failure to adequately test component samples for identity, purity, strength, and quality, and to validate supplier test analyses. Specifically, the company ceased testing purified water after 2022, a critical component for pediatric oral homeopathic drugs, without ensuring its suitability or testing for potential contaminants like Burkholderia cepacia complex (BCC). Inadequate testing of botanical components was also noted. Furthermore, Siddha Flower Essences failed to thoroughly investigate out-of-limit microbiological contamination found in finished drug products, including unidentified gram-negative growth, which poses an unacceptable risk, especially to children. The company also failed to update its drug listings as required by the FD&C Act, leading to misbranded products. The FDA requires a comprehensive, independent review of the company"s material system, including supplier qualification and component testing protocols, and a robust program for investigating contamination and ensuring product quality.