Dyno Manufacturing, Inc. – FDA Warning Letter, Nov 1, 2024

The FDA issued a Warning Letter to Dyno Manufacturing, Inc. following an inspection from October 28 to November 1, 2024, citing significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Failure to test components:** The firm did not adequately test incoming raw materials (e.g., ethanol, glycerin, propylene glycol) for identity, including high-risk components for DEG/EG contamination (glycerin) and methanol (ethanol). They relied on supplier Certificates of Analysis (COAs) without validating their reliability, despite being aware of testing requirements. 2. **Lack of stability testing:** The firm failed to establish a stability testing program to support the assigned expiration dates for OTC hand sanitizer and antibacterial hand soap, and lacked an approved stability program procedure. Their proposed interim remediation was deemed inadequate. 3. **Inadequate production and process controls:** The firm failed to validate production and process controls, lacking a process validation program and data for parameters like mixing. Equipment qualification and cleaning validation studies were also incomplete. 4. **Quality Control Unit deficiencies:** The Quality Unit failed to adequately exercise its responsibilities, including ensuring CGMP compliance and conducting adequate oversight, and their response regarding annual product reviews was insufficient.

The FDA recommended engaging a qualified CGMP consultant. The firm must respond within 15 working days, detailing corrective actions and prevention plans. Failure