Genuine Virgin Aloe Corp – FDA Warning Letter, Jan 29, 2024

On July 1, 2024, the FDA issued a Warning Letter to Genuine Virgin Aloe Corp, dba Triderma, following an inspection from January 17-29, 2024, at their Anaheim, CA drug manufacturing facility. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to test components:** The firm failed to adequately identity test incoming raw materials (e.g., salicylic acid, allantoin, colloidal oatmeal) and did not validate supplier COAs. Crucially, they failed to test high-risk components like glycerin for diethylene glycol (DEG) or ethylene glycol (EG) contamination, which can be lethal. Their response was inadequate, lacking details on identity testing and assessing distributed products. 2. **Inadequate production and process controls:** The firm failed to validate manufacturing processes and qualify equipment. Their response was insufficient, not committing to prospective validation before distribution or providing a risk assessment for marketed products. 3. **Insufficient stability program:** The firm lacked an adequate stability program to determine appropriate expiration dates, assigning three-year expiries without supporting data. Their response did not confirm the use of validated stability-indicating methods. 4. **Inadequate quality unit (QU):** The QU failed to provide adequate oversight of CGMP records (e.g., incomplete batch records) and did not follow procedures