FDA 483 - Custom RX LLC - August 15, 2017

An FDA Form 483 was issued to Custom RX, LLC, a producer of sterile and non-sterile drugs located in Wichita, KS, following an inspection conducted from July 31 to August 15, 2017. The document highlights significant observations regarding the firm's adherence to regulatory standards, specifically concerning aseptic processing and facility cleanliness.

One primary concern was the failure to prevent contamination in the aseptic production area (ISO 5 hood). An operator was observed spraying gloves with a sterile substance directly over open vials containing finished sterile drug product. Furthermore, the firm's media fills were deemed not representative of actual aseptic production operations, indicating a potential weakness in contamination control validation.

The inspection also noted a failure to adequately clean or disinfect the ISO 5 hood and associated equipment. There was no documentation to confirm that the production area was cleaned to remove smoke residue after smoke studies, even though sterile drug products were produced afterward. Additionally, a commercial liquid dishwashing soap was found in the Ante Room and management confirmed its use for washing glassware intended for the sterile hood, which is inappropriate for aseptic environments.

These observations from the FDA inspection indicate areas where Custom RX, LLC needs to improve its manufacturing practices to ensure product quality and patient safety. The firm is expected to address these findings and implement corrective actions in response to the reported deficiencies.