FDA 483 - DA BOMB LLC - May 05, 2025
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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.
ID · d7a4fea4-90e8-4c4a-aac6-0b2916c099d8