FDA 483 - Right Value Drug Stores LLC - May 12, 2017

During an inspection conducted from April 25 to May 12, 2017, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Right Value Drug Stores, Inc., an outsourcing facility located in Hurst, TX. The inspection revealed several significant observations related to the company's manufacturing and quality control practices, highlighting areas of non-compliance with regulatory expectations for drug product manufacturing.

Key issues included the absence of written and validated procedures for equipment cleaning and maintenance, which raised concerns about potential cross-contamination. The firm's Quality Control Unit failed to adequately review batch production records, leading to numerous omissions in documentation of critical manufacturing steps and materials. Furthermore, the company did not perform preservative effectiveness tests on multi-dose injectable drug products, compromising assurance of product stability and sterility over time. Batch production records were found to be incomplete and inaccurate, failing to reflect all significant manufacturing operations.

Additionally, Right Value Drug Stores, Inc. did not meet regulatory requirements for outsourcing facilities by failing to submit product reports to the FDA upon initial registration. The labeling for several drug products also lacked essential information for adverse event reporting, as mandated by federal regulations.

To address these observations, Right Value Drug Stores, Inc. is required to implement comprehensive corrective actions. These actions should include developing and validating robust cleaning procedures, enhancing the rigor of its Quality Control Unit's review processes, establishing and conducting appropriate stability and preservative effectiveness testing, ensuring complete and accurate batch documentation, and fully complying with FDA reporting and labeling mandates for outsourcing facilities.