Scientific Solutions Global LLC – FDA Warning Letter, Jan 2, 2019

The FDA issued a Warning Letter to Scientific Solutions Global LLC following an inspection from December 11, 2018, to January 2, 2019, identifying significant CGMP violations and the manufacture of unapproved new drugs.

Key violations include: 1. **Lack of Finished Product Release Testing:** The firm admitted to not performing release testing for BIOTEMPER and UREA 40+Salicylic Acid, and having no system for drug product release. 2. **Inadequate Component Identity Testing:** The firm failed to perform identity testing on raw materials, relying solely on supplier Certificates of Analysis without validating their reliability. 3. **Absence of Process Validation:** No process validation was conducted for any manufactured drug products, indicating a lack of control over manufacturing processes. 4. **Deficient Quality Control Unit (QCU):** The QCU failed to establish adequate specifications, ensure batch testing before distribution, and implement a stability program.

The FDA cited 21 CFR, parts 210 and 211, deeming the drug products adulterated. Additionally, products like BIOTEMPER COLD PAIN RELIEF THERAPY, UREA 20, UREA 40, bare20, bare40, bare40+Salicylic Acid, and bare40+Hyaluronic Acid were identified as unapproved new drugs, violating sections 505(a) and 30