FDA 483 - RC Compounding Services, LLC - February 16, 2018

This FDA Form 483 details observations from an inspection on February 12-13, 2018, concerning sterile drug production.

**Facility and Operations:** The facility produces sterile drug products, including Serum Tears, Testosterone Cypionate 200 mg for injection, and Epinephrine/Lidocaine Intraocular Solution 0.01 mg:20 mg/ml. Production occurs in ISO 5 Laminar Air Flow Hoods and ISO 7 cleanrooms/anterooms. Hazardous drugs like tacrolimus, testosterone, and progesterone are produced in the same ISO 5 hood as non-hazardous drugs.

**Violations and Observations:** 1. **Airflow Obstruction:** On 02/12/2018, during Serum Tears production in the ISO 5 hood, an employee placed caps and containers in a pile, blocking first-pass ISO 5 airflow. 2. **Non-Sterile Disinfectants/Wipes:** On 02/13/2018, non-sterile (b)(4) was used with sterile wipes to clean the ISO 5 hood. The non-sterile solution was also sprayed outside the hood, potentially entering the ISO 5 area. 3. **Improper Gowning:** On 02/12/2018, an employee donned non-sterile gloves, then touched sterile gloves with them,