FDA 483 - DA BOMB LLC - May 05, 2025

DA BOMB LLC, a drug manufacturer in Minneapolis, MN, received a Form 483 with four observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality control unit, lacking essential procedures for component testing, stability programs, record-keeping, and complaint handling. Additionally, the company failed to adequately test components and finished drug products for identity and strength, and had not performed process validation for its hand sanitizer manufacturing.