Vitalab Pharmacy, Inc. – FDA Warning Letter, Apr 4, 2018

This FDA Warning Letter, dated February 12, 2019, addresses Vitalab Pharmacy, Inc., dba Vasco Rx, following an inspection from March 26 to April 4, 2018. The inspection revealed serious deficiencies in sterile drug product production, leading to drug products being adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Key violations include: 1. **Deficient laminar airflow hood design:** The (b)(4) laminar airflow hood had a ledge and gap, creating difficult-to-clean surfaces, and smoke studies showed turbulent airflow. 2. **Use of non-sterile wipes:** Non-sterile wipes were used in aseptic processing areas. 3. **Poor aseptic practices:** A technician's head was inside the laminar flow hood, and a gloved hand contacted the inner surface of a container closure during aseptic production. 4. **Inadequate media fills:** Media fills were not performed under challenging conditions, lacking assurance of aseptic production.

The FDA acknowledged the firm ceased sterile drug production in the (b)(4) laminar airflow hood on April 4, 2018, and voluntarily recalled all affected sterile products on April 24, 2018. However, the firm's July 31, 2018, response to the Form FDA 483 lacked sufficient