FDA WARNING_LETTER - LiquidCapsule Manufacturing, LLC - July 03, 2025

The FDA issued a Warning Letter to LiquidCapsule Manufacturing, LLC, following an inspection of their Tampa, Florida drug manufacturing facility from June 25 to July 3, 2025. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, indicating that the company’s drug products are considered adulterated. A primary issue was the failure to adequately test incoming components for identity, purity, strength, and quality, especially for high-risk drug components, and relying on supplier Certificates of Analysis (COAs) without proper validation. This means the company lacked scientific evidence that components met required specifications before use. The FDA also noted the absence of retrospective review for previously distributed products that used inadequately tested components. Additionally, LiquidCapsule Manufacturing failed to establish scientifically sound laboratory controls. For instance, they used an unvalidated test method for assaying a critical drug component without demonstrating its equivalence to recognized standards, compromising assurance of product identity and quality. Lastly, the company did not have an adequate written program for stability testing to ensure that drug products consistently meet specifications and maintain their quality throughout their labeled shelf lives. The FDA requires comprehensive corrective actions. These include providing detailed plans for testing each incoming component lot for all specifications, robustly validating supplier COAs, and committing to specific identity tests. The company must also conduct a thorough assessment of laboratory practices, methods, and equipment, providing a detailed remediation plan. Furthermore, an adequate stability testing program must be established and followed to support product shelf life. The FDA found the company"s initial responses to be insufficient due to a lack of detail and retrospective analysis.