FDA 483 - Right Value Drug Stores LLC - June 27, 2022

During an inspection conducted from June 7 to June 27, 2022, the U.S. Food and Drug Administration issued a Form FDA 483 to Right Value Drug Stores, LLC, operating as Carie Boyd's Prescription Shop, an outsourcing facility in Irving, TX. The observations indicate significant concerns regarding the facility's adherence to regulatory requirements for drug manufacturing, particularly affecting the sterility and quality assurance of compounded products. Key violations include a failure to thoroughly investigate environmental monitoring excursions, where various microorganisms were found in critical aseptic processing areas, without proper product impact assessments or root cause analysis. The firm's environmental monitoring system itself was found deficient, with active air sampling not conducted during production and non-viable particle probe placement lacking justification and stability. Furthermore, aseptic and sterilization processes lacked adequate validation, including unrepresentative smoke studies and uncertified cleanrooms under dynamic conditions. Additional issues encompass the use of non-sterile components for sterile products without proper cleaning/sterilization, inadequate cleaning and maintenance of equipment, and deficiencies in batch production records. The facility also lacked written procedures for the receipt and testing of raw materials and failed to properly calibrate analytical equipment. Significantly, the firm did not submit required reports to the FDA identifying compounded drugs and failed to include essential information, such as the route of administration, on drug product container labels. These observations necessitate prompt corrective actions to ensure patient safety and product quality.