FDA 483 - fusion iv pharmaceuticals, inc. - March 23, 2017

The FDA Form 483 details numerous deficiencies at an outsourcing facility producing sterile drug products.

**Facility and Operations:** The facility utilizes ISO 5 Laminar Flow Workstations (LAFWs) and an ISO 5 filling room with a PennTech automated vial filling machine. Products include Total Parenteral Nutrition (TPN), Methylcobalamin, Methionine/Inositol/Choline (MIC) Injectable, Testosterone Cypionate, Human Chorionic Gonadotropin (HCG), Hydroxocobalamin, Methylprednisolone Acetate, Chromium Picolinate, Ascorbic Acid, B-Complex, Cyanocobalamin, Pyridoxine Hydrochloride, Glutathione, Triamcinolone Diacetate, and Dexamethasone LA.

**Violations and Observations:** * **Sterility Failures & Investigations:** Failure to investigate root causes of media fill sterility failures in ISO 5 LAFWs from (b)(4), with observed turbidity in growth promotion media. * **Media Fill Validation:** No media fill validation runs performed on the PennTech automated vial filling machine, despite producing (b)(4) batches of sterile drug products between (b)(4). * **Environmental Control:** No Smoke Pattern Test performed in the ISO 5 Filler Room. An individual's arm was observed obstructing unidirectional airflow during TPN preparation in an ISO 5 workstation. * **Growth Media Testing:** Failure to perform growth media