FDA 483 - First Pharma Associates LLC dba Riverpoint Pharmacy - June 07, 2019

The FDA Form 483 documents multiple violations at a facility producing sterile and non-sterile drug products.

**Facility and Operations:** The facility includes an ISO-7 Buffer room with an ISO-5 Biological Safety Cabinet (BSC) for sterile drug production, an ISO-7 Ante room for weighing and compounding, an ISO-8 Gowning room, and a non-sterile processing laboratory.

**Violations and Observations:**

* **Non-microbial Contamination:** An unidentified object was found on the floor of the ISO-7 Buffer room on June 3, 2019. * **Aseptic Technique Breaches:** * Personnel manually contacted the inner surface of vials during stoppering of Prostaglandin 20mcg/ml Procaine 0.1% Injection on June 5, 2019, inside the ISO-5 BSC. * Technician's hand blocked first-pass air during aseptic compounding of Serum Tears 20% Eye Drops PF solution on June 3, 2019. A tray of caps and tips was also placed in front of return air vents in the ISO-5 BSC. * **Cross-Contamination (Hazardous Drugs):** * Inadequate deactivation of hazardous products in the (b)(4) hood (Model (b)(4), SN (b)(4)) in the ISO-7