FDA 483 - Johnson Memorial Cancer Center - October 21, 2021

During an inspection from September 20 to October 21, 2021, the FDA observed four violations at Johnson Memorial Cancer Center, a producer of sterile drug products in Enfield, CT.

**Observation 1:** The facility produced hazardous drugs without adequate cleaning of work surfaces to prevent cross-contamination. A pharmacy technician failed to clean the internal view screen of the ISO 5 Biological Safety Cabinet (BSC) between producing different sterile drug products (Cisplatin, Pembrolizumab, Etoposide) on September 21, 2021. On September 22, 2021, another technician failed to clean the BSC view screen immediately prior to producing Bortezomib. Additionally, the technician used an inappropriate "mop handle" with sterile wipes, preventing complete cleaning of the BSC interior.

**Observation 2:** Materials or supplies were not disinfected prior to entering aseptic processing areas. On September 22, 2021, a pharmacy technician failed to clean the septum of two sterile drug product vials with Sterile (b)(4) immediately prior to producing Bortezomib.

**Observation 3:** The facility had inadequate HEPA filter coverage and airflow over areas exposed to sterile products. Smoke studies conducted on August 21, 2020, February 22, 2021, and August 19, 2021, for the ISO 5 BSC