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Talk to a SpecialistTalk to a SpecialistVitae Enim Vitae Scientific Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacturing of sterile drug products at its San Diego facility during a September 2021 inspection. The company failed to establish and follow written procedures to prevent microbiological contamination of sterile drugs, specifically lacking required smoke studies in ISO 5 classified areas to validate aseptic processing—having manufactured and distributed products since January 2020 without this essential validation. The FDA found the company's October 2021 response to inspection findings inadequate, as it did not provide sufficient corrective action details or evidence to bring operations into compliance with CGMP regulations.