FDA 483 - Eagle Pharma Outsourcing LLC - August 12, 2021

The FDA Form 483 details deficiencies observed during an inspection of a facility involved in aseptic processing and drug product manufacturing.

**Facility and Operations:** The facility produces sterile drug products, including Triamcinolone, Betamethasone, Dexamethasone, and Methylprednisolone, in vial and suspension forms. Operations involve vial filling in ISO-5 classified areas and stability testing.

**Violations and Observations:**

1. **Environmental Monitoring Deficiencies:** * Surface sampling in the ISO-5 vial filling room is not conducted in the most critical areas (center of LAFW) where aseptic manipulations occur, but rather on outer areas. * The particle counting probe for non-viable particles in the ISO-5 vial filling machine is positioned greater than (b)(4) from the most critical area, failing to obtain a meaningful sample.

2. **Aseptic Processing and Sterilization Validation Deficiencies:** * **Cleaning and Disinfection:** The system for cleaning and disinfecting aseptic processing areas to achieve aseptic conditions is deficient. * **Smoke Study:** A June 2020 smoke study revealed turbulence within the ISO-5 classified area of the (b)(4) vial filling machine at critical production points during routine interventions. * **Sterilization Validation:** The (b)(4) validation by a third-party contractor did not adequately specify a load pattern for Triamcinolone in (b