FDA 483 - Sentara Infusion Services - December 16, 2022

During an FDA inspection from December 5-16, 2022, Sentara Infusion Services, a producer of sterile drug products located at 535 Independence Pkwy Ste 300, Chesapeake, VA, received a Form 483 with ten observations.

Key violations include: 1. **Non-sterile cleaning agents:** Disinfecting agents and wipes used in ISO 5 aseptic processing areas were not sterile. Non-sterile wipes were used as work surfaces and for cleaning. Disinfectant contact times were insufficient. 2. **Inadequate microbial contamination response:** Actionable microbial contamination was consistently found in ISO 7 areas (adjacent to ISO 5 aseptic processing areas) since November 2020, including Penicillium sp., Exserhilum sp., Hormographiella sp., Cladosporium sp., Geotrichum sp., Coagulase (-) Staphylococcus sp., Bacillus sp., Trichoderma sp., and Aspergillus sp. Product evaluation and remedial actions were deemed inadequate. 3. **Cross-contamination risk:** Inadequate cleaning of work surfaces after beta-lactam drug production was observed, with spillage not being deactivated or removed, posing a cross-contamination risk to subsequent non-beta-lactam products. 4. **Personnel gowning deficiencies:** Technicians were observed with exposed wrists and exposed hair in ISO 5 classified laminar airflow hoods during sterile drug production. 5. **