FDA 483 - People's Custom Rx and Clinical Care, LLC - August 05, 2021

This FDA Form 483 documents observations from an inspection, highlighting deficiencies in aseptic processing and environmental controls.

**Facility and Operation Details:** The firm compounds both sterile and non-sterile drug products. Sterile drug products, such as Cyclosporine 1%, are produced in batch sizes up to (b)(4). Non-sterile drug products are continuously processed in a dedicated compounding area.

**Violations and Observations:**

1. **Aseptic Processing Simulation (Media Fills):** Media fills did not adequately simulate aseptic production operations, particularly worst-case activities and conditions. While the firm's sterile drug product compounding involves multiple aseptic manipulation steps and batch sizes up to (b)(4), current media fills are performed only with (b)(4). This suggests a lack of challenge to the aseptic operations commensurate with actual production.

2. **Pressure Differential Monitoring:** Pressure differentials between areas with different air classifications were not monitored prior to or during sterile drug production. There is no verification of these differentials before or during production. The (b)(4) used for measurement are not visible from within the cleanroom, and there is no alarm system to signal out-of-specification room pressures. Pressure differential values are only recorded (b)(4).

3. **Non-Microbial Contamination:** Non-microbial contamination was observed in the non-sterile drug production area. On July 13, 2021, drug product residue was