FDA 483 - RX South DBA RX3 Compounding Pharmacy LLC - April 18, 2016

This FDA Form 483 documents observations from an inspection of a facility producing sterile drug products.

**Facility and Operations:** The facility engages in aseptic processing of injectable drug products, including Phenylephrine HCL, IC Rescue Solution, 100% Glycerin Injectable, Testosterone Cypionate (Sesame) 200mg/ml injectable, Methylcobalamin 25mg/ml (PF) injection solution, and Prostaglandin (UD) 500mcg/ml injectable. Operations involve ISO 5 Laminar flow hoods and ISO 7 areas.

**Violations and Observations:**

* **Aseptic Processing Area Maintenance:** Brown stains were observed on a HEPA filter in an ISO 5 Laminar flow hood, and rusty conditions were noted on the metal support structure beneath an ISO 5 Laminar flow in the IV room. * **Cleaning and Disinfection:** Cleaning records from January 1 to March 31, 2016, did not show the use of sporicidal disinfectant in ISO 5 Laminar flow hoods or ISO 7 areas; only sterile disinfectant was documented for ISO 5 hoods. * **Sterilization Process Validation:** * The sterilization process for 100% Glycerin Injectable was not validated, despite lots 103240216@31 and 10328201