FDA 483 - BSO LLC - July 16, 2025

**FDA 483 Summary for BSO LLC**

**Inspection Details:** - **Company Name:** BSO LLC - **Inspection Dates:** July 7, 2025, to July 16, 2025 - **Location:** Lakewood, CO - **Type of Facility:** Outsourcing Facility

**Main Violations/Issues:** 1. **Microbiological Contamination Prevention:** Procedures to prevent contamination in sterile drug products were inadequately validated. Specifically, there was no potency data for products in new clear vial packaging, and sterility methods lacked necessary challenge microorganisms, compromising sterility assurance.

2. **Employee Training Deficiencies:** Personnel lacked comprehensive training for visual inspection of liquid injectable products, missing examples of critical defects, which could lead to undetected sterility risks.

3. **Inadequate Production Procedures:** The firm"s SOP for visual inspection of pellets failed to classify defects by severity, lacked defined acceptance criteria, and did not ensure inspections under proper conditions, risking the release of defective products.

4. **Stability Program Deficiencies:** Stability studies were not conducted in the current packaging system, questioning the validity of assigned expiration dates for marketed products.

**Regulatory Framework:** The observations are based on FDA regulations requiring validated processes to ensure drug safety, efficacy, and quality, particularly for sterile products.

**Required Actions:** - Validate sterilization processes with appropriate potency and sterility data for current packaging. - Enhance employee training programs to cover all critical defect types. - Revise SOPs to include defect classification, acceptance criteria, and proper inspection conditions. - Conduct stability studies in the current container-closure system to confirm product expiration dates.

These actions are necessary to ensure compliance and maintain product integrity and patient safety.