FDA 483 - Custom Compounding Center - June 04, 2019

This FDA Form 483 document details inspectional observations made at Custom Compounding Center, located at 11700 Kanis Rd, Little Rock, AR 72211-3729. The firm is identified as a Producer of Drug Products. The inspection was conducted from May 29, 2019, to June 4, 2019. Mr. Mark Shinabery, the Owner, was the individual to whom the report was issued.

The sole observation noted was: "You produced hazardous drugs without providing adequate cleaning of work surfaces to prevent cross-contamination." Specifically, the firm failed to utilize an oxidizing agent for cleaning immediately after handling testosterone, estrogen, and morphine-containing drug products in their hoods, identified by serial numbers (b)(4) I and (b)(4) II. The firm's standard operating procedure, "Room Cleaning Procedures and Spill Handling," SOP #3.007, only specifies the use of (b)(4) for cleaning between compounding drug products. This indicates a deficiency in cleaning protocols for preventing cross-contamination of hazardous drugs.