new vitalis, llc – FDA Warning Letter, Aug 27, 2021

On May 18, 2022, the FDA issued a Warning Letter to New Vitalis, LLC dba New Vitalis Pharmacy, following an inspection from August 23-27, 2021. The inspection revealed serious deficiencies in the production of sterile drug products, leading to adulterated drugs under FDCA Section 501(a)(2)(A).

Violations included: 1. Vermin observed near the production area. 2. Production areas with difficult-to-clean, porous, particle-generating, or dirty surfaces (e.g., debris, peeling tape with black residue, black residue around HEPA filters). 3. Operator blocking first air with gloved hands over open sterile containers. 4. Unsealed HEPA filters. 5. Personnel failing to disinfect gloves and components. 6. Improper gowning procedures. 7. Inadequate cleaning of utensils for hazardous drug products, risking cross-contamination.

New Vitalis voluntarily recalled Testosterone Cypionate/Testosterone Propionate 180mg/mL, 20mg/mL produced on or prior to September 7, 2021, and ceased all sterile compounding effective September 7, 2021. The FDA noted that the firm's responses to the Form FDA 483 did not adequately address the insanitary conditions. The FDA strongly recommended a comprehensive assessment of operations by a third-party