FDA 483 - VA New Jersey Health Care System - February 27, 2020

The FDA Form 483 documents observations from an inspection of a facility producing sterile intravenous (IV) drug products in ISO 5 classified aseptic processing areas, including a Biological Safety Cabinet and a Laminar Air Flow Hood.

Multiple violations were noted: 1. **Personnel Practices:** On February 11, 2020, a pharmacy technician touched equipment outside the ISO 5 area with gloved hands and then engaged in aseptic processing of Rituxan without changing or sanitizing gloves. 2. **Environmental Control during Construction:** On February 7, 2020, drug production occurred while 2-3 maintenance personnel performed ceiling tile work and construction approximately 5 feet from the Ante room entrances to both Hazardous and Non-Hazardous ISO 5 areas, without adequate contamination controls. 3. **Pest Control:** On February 7, 2020, a gnat was observed by the Ante Room entry door, approximately 2 feet from the Hazardous Room where sterile admixture occurs. 4. **Facility and Equipment Cleanliness:** * **ISO 5 Areas:** Visible white cluster powder buildup was on the Laminar Air Flow Hood's fluorescent light cover on February 7, 2020, during production of Vasopressin, Ferric Gluconate, and Meropenem. On February 11, 2020, white dusty powder residue was on a stainless