FDA 483 - Right Value Drug Stores LLC - July 18, 2025

**FDA 483 Summary for Right Value Drug Stores LLC**

**Inspection Details:** - **Company:** Right Value Drug Stores LLC - **Location:** 8400 Esters Blvd Ste 190, Irving, TX 75063-2217 - **Inspection Dates:** July 7, 2025 - July 18, 2025 - **Type of Establishment:** Outsourcing Facility

**Main Violations/Issues:** 1. **Failure to Investigate Discrepancies:** The firm did not thoroughly investigate unexplained discrepancies in sterile injectable drug products, specifically regarding dark particulate contamination in Testosterone Cypionate and Testosterone Propionate products. Despite identifying numerous contaminated vials, no root cause analysis or particle characterization was conducted before product release.

2. **Lack of Validated Procedures:** The company lacks validated procedures for in-process controls and testing of work-in-progress materials, specifically hormonal pellets stored in a dry cabinet. This is a repeat observation indicating ongoing non-compliance.

3. **Inadequate Microbiological Contamination Prevention:** The firm failed to conduct appropriate smoke studies for biological safety cabinets in a dynamic state, and personnel monitoring and environmental sampling procedures were not properly followed, risking contamination during aseptic processing.

4. **Inappropriate Equipment Design:** The equipment used, specifically a dry cabinet, did not meet the necessary design standards to ensure it performs its intended function, compromising product quality.

**Regulatory Framework:** The observations are based on the FDA"s regulatory standards for drug manufacturing, focusing on quality control, contamination prevention, and equipment validation.

**Required Actions:** - Conduct thorough investigations into particulate contamination, including root cause analysis and particle characterization. - Develop and validate procedures for in-process testing of materials. - Revise and implement proper microbiological contamination prevention practices, including adequate smoke studies and sampling procedures. - Ensure equipment meets design and operational standards through proper qualification protocols.

The firm is expected to address these issues promptly to comply with FDA regulations and ensure