FDA 483 - infusion systems of sw florida inc. - December 22, 2014

This FDA Form 483 document details observations made during an inspection related to the manufacturing of sterile drug products.

**Facility and Operation Details:** The inspection focused on the preparation of sterile drug products, specifically within a laminar flow hood (ISO 5) and a Buffer room.

**Violations and Observations:** * **Sterilization Process Validation:** Procedures for preventing microbiological contamination of sterile drug products lack validation of the sterilization process. * **Aseptic Deficiencies:** * Personnel did not sanitize items (e.g., bags containing vials, syringes, and REDACTED) before placing them into the laminar flow hood. * Personnel rested forearms inside the laminar flow hood during sterile drug preparation. * Personnel entered the Buffer room with non-sterile gloves, removed them inside the laminar flow hood, and exposed bare hands while donning sterile gloves. * Personnel did not periodically sanitize gloves with REDACTED during sterile drug preparation. * Bare skin (forearms) was exposed under the laminar flow hood due to ill-fitting gowns. * **Environmental Monitoring:** Aseptic processing areas have deficient systems for monitoring environmental conditions. * **Cleaning and Disinfection:** Aseptic processing areas have deficient systems for cleaning and disinfecting rooms and equipment to achieve aseptic conditions. * **Protective Apparel:** Protective apparel is not worn as necessary to protect drug products from contamination. *