FDA 483 - BSO, LLC - June 27, 2025

**FDA 483 Summary for BSO, LLC**

**Inspection Dates:** June 16-27, 2025 **Location:** Golden, CO **Company:** BSO, LLC **Type of Establishment:** Outsourcing Facility **Executive Contact:** Mr. Robert J. Kilgore, CEO

**Main Violations/Issues:**

1. **Sterilization Process Validation:** The FDA observed that BSO, LLC did not adequately validate the sterilization process for Estradiol Pellets. The firm failed to document sufficient validation for the new container-closure system and did not conduct a method suitability study or calculate a recovery factor for microbial recovery efficiency. The studies provided did not reflect the current packaging configuration, which could affect product potency and performance.

2. **Production and Process Controls:** The company lacked adequate written procedures to ensure drug products meet identity, strength, purity, and quality standards. Specifically, the visual inspection procedures did not include criteria for operator re-qualification, leading to potential oversight of defects such as "Black Speck" and "Contaminant in vial." This issue was compounded by the release of batches without resolving the root cause of these defects.

3. **Stability Program Deficiencies:** The stability program did not include specific test methods, notably lacking photostability studies for light-sensitive products.

**Regulatory Framework:** The observations are inspectional and not a final determination of compliance. BSO, LLC is expected to address these issues under the FDA"s regulatory framework to ensure product safety and efficacy.

**Required Actions:** BSO, LLC must implement corrective actions, including validating the sterilization process for current configurations, revising visual inspection procedures to include re-qualification criteria, and enhancing the stability program to include necessary test methods. The firm should also investigate and resolve the root cause of observed defects before releasing products.