FDA 483 - Rx Unlimited Pharmacy - October 21, 2022

The FDA Form 483 details multiple violations at a drug compounding facility. The facility produced hazardous drugs without adequate cleaning of work surfaces and utensils, failing to demonstrate that cleaning solutions deactivate hazardous drug substances to prevent cross-contamination. Since July 12, 2022, approximately (b)(4) patient prescriptions of hazardous drugs, including BI-EST/Progesterone/Testosterone Cream and Hydroquinone/Hydrocortisone/Tretinoin Cream, were dispensed.

The company used a non-pharmaceutical grade component, (b)(4) from their (b)(4) system, as (b)(4) in non-sterile drug products and (b)(4) without microbial or analytical testing. The (b)(4) system was not qualified, validated, or maintained. Since May 2022, (b)(4) drug product formulations (nasal spray, oral suspension, oral and topical solutions) using (b)(4) were produced, with (b)(4) patient prescriptions dispensed in the last three months, including Misoprostol/Diphenhydramine HCl/Lidocaine HCl Oral Rinse and Minoxidil/Finasteride/Bimatoprost Topical Solution.

Personnel donned gowning apparel improperly; on October 17, 2022, a technician's sterile coverall contacted a handwashing sink in the ISO 8 Ante Room and was not changed before entering the ISO 7