FDA WARNING_LETTER - Vitae Enim Vitae Scientific Inc. - September 22, 2021

The FDA inspected Vitae Enim Vitae Scientific Inc. in San Diego, CA, from September 13-22, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. The firm's October 11, 2021, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b))**: Deficiencies in smoke studies (not performed dynamically, inadequate visualization, reliance on insufficient tests), design flaws in ISO 5 areas and aseptic processing lines (insufficient HEPA airflow, alarming filling machine), and inadequate operator gowning. Process simulation deficiencies included untrained personnel for media fill vial examination. 2. **Inadequate environmental monitoring (21 CFR 211.42(c)(10)(iv))**: Lack of active viable air sampling during aseptic processing, and insufficient details in procedures regarding alert levels, sampling frequency, duration, size, deviation response, and trend evaluation. 3. **Quality control unit failures (21 CFR 211.22)**: Inadequate oversight of contract testing laboratories (failure to ensure method validation/verification for raw material, release, and stability tests), and inadequate qualification of suppliers (e.g., new sterile (b)(4) supplier, removal