One Way Drug DBA Partell Specialty Pharmacy – FDA 483, Mar 8, 2018

The FDA Form 483 details multiple deficiencies at a facility producing sterile drug products, including large volume batches and pellet products like Estradiol, Naltrexone, and Testosterone.

Key violations include: - **Inadequate Sterilization Processes:** The (b)(4) used for large volume batches is not pharmaceutical grade and its suitability is not tested. The (b)(4) used for sterilization lacks assurance of integrity, with discrepancies in required (b)(4) for (b)(4) testing. - **Unverified Sterilization Cycles:** (b)(4) pellet products are compounded and filled in an unclassified Biosafety Cabinet within an unclassified room. The (b)(4) sterilization cycle for pellets and container-closures is not verified to be lethal to (b)(4) microorganisms. The (b)(4) incubator for Biological Indicators is not calibrated and lacks a visual thermometer. Scientific justification for the (b)(4) cycle for sealed pellet products is absent. - **Non-Sterile/Non-Depyrogenated Components:** Non-sterile stoppers and vials are not depyrogenated before filling aseptically filled and (b)(4) sterilized pellet drug products. - **Non-Sterile Cleaning Agents:** Non-sterile wipers, dry wipes, and (b)(4) are used to clean the ISO-5 Laminar Air Flow Hood. - **Inadequate Sporicidal Agent Use:** Contact times for disinfect