FDA 483 - IV Solutions of Lubbock - June 08, 2007

During an FDA inspection conducted from June 5-8, 2007, IVSolutions of Lubbock, a compounding pharmacy, received a Form FDA 483 outlining significant observations related to their sterile compounding operations, specifically for Colistimethate Sodium for Inhalation. The inspection revealed several critical deficiencies. The company failed to routinely test the product for sterility and potency, which are essential for ensuring drug safety and efficacy. The assigned ninety-day expiration date lacked a formal, approved stability testing protocol, and the "test batch" used for stability was unrepresentative of routine production volumes. Furthermore, there was an absence of records and traceability for materials used in this test batch. Environmental controls in the sterile products preparation room were found to be inadequate, as the policy did not address door openings that could compromise airflows, and supplies were improperly stored within laminar flow workstations. A technician was observed using an inappropriate hand sanitizer during aseptic filling, which is contrary to sterile drug product procedures. The firm also lacked shipping studies or controls to ensure that refrigerated products maintained their required temperature during transit. Finally, patient complaints regarding melted ice-packs during shipment were not consistently documented or investigated, indicating a failure in their complaint handling process. Addressing these observations is crucial for the company to ensure the quality and safety of its compounded sterile products.