FDA 483 - Reliant Compounded Solutions Monroe, LLC - August 29, 2019

This FDA Form 483 details nine observations from an inspection.

**Observation 1** notes the use of a non-pharmaceutical grade component, specifically a partially used, reconstituted 1-gram vial of Ceftazidime for Injection USP (NDC 44567-235-25, Lot 06072019). This single-dose vial, reconstituted on 6/7/19 with a 90-day Beyond Use Date (BUD), was subsequently used for sterile-to-sterile production of eye drops and intravitreal products on 6/7/19, 6/11/19, 7/8/19, and 8/5/19, each assigned a 14-day BUD. The Ceftazidime package insert states a 12-hour room temperature or 3-day refrigerated potency, or 3 months frozen at -20°C, and should not be refrozen once thawed.

**Observation 2** identifies difficult-to-clean, particle-generating, and visibly dirty equipment in ISO 5 aseptic processing areas. The hazardous ISO Class 5 Biological Safety Cabinet (BSC) had duct tape along the shield frame groove and cracks in the sash (shield).

**Observation 3** reports non-microbial contamination. Rust was observed on the exterior of both hazardous and non-