FDA WARNING_LETTER - Trilogy Laboratories, LLC - August 27, 2019

The FDA inspected Trilogy Laboratories, LLC from August 22-27, 2019, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). Consequently, the firm's drug products are adulterated under section 501(a)(2)(B) of the FD&C Act. Specific CGMP violations included failure to perform appropriate laboratory testing for drug product release, failure to verify component identity and validate supplier analyses, and inadequate written procedures for production and process control.

Additionally, several products were cited for unapproved new drug and misbranding violations. “AZUL Gly Sal Pads,” “AZUL Acne Defense Cream,” and “Azul DermaBright HQ Serum” are unapproved new drugs, violating section 505(a) of the FD&C Act, as they are not generally recognized as safe and effective and lack FDA approval. These products, along with “AZUL Gly Sal Pads” and “AZUL Acne Defense Serum,” are also misbranded under section 502(c) for failing to include a Drug Facts panel. “Azul DermaBright HQ Serum,” “daily eclipse tinted Broad Spectrum SPF 30,” and “daily eclipse Broad Spectrum SPF 30” are misbranded under section 502(x) for lacking a domestic address or phone number for adverse event reporting. Furthermore, “AZUL Satin Eclipse Broad Spectrum SPF 32” is misbranded under section 502(a) due to false and misleading SPF labeling.

The firm's September 18, 2019, response to the FDA 483 was deemed inadequate. The FDA acknowledges the firm's commitment to cease drug production but requires clarification on future manufacturing plans. The firm must promptly correct all cited violations within 15 working days, providing a detailed response and schedule. Failure to comply may lead to legal action, including seizure and injunction, and impact federal contracts or product approvals. A face-to-face regulatory meeting will be scheduled to ensure corrective actions.