FDA 483 - BSO LLC - March 11, 2021

The FDA Form 483 documents observations from an inspection of an outsourcing facility compounding drugs such as Testosterone Pellets.

**Violations and Observations:**

1. **Inadequate Investigation of Discrepancies:** Written records of investigations into unexplained discrepancies, specifically environmental monitoring (EM) excursions, lack thorough conclusions and follow-up. For example, Non-Conformance Investigation INV20018 for EM excursions on 7/14/20 and 7/28/20 in the ISO 8 Clean Room (gowning room computer area), where Testosterone Pellets are made, showed surface viable monitoring exceeding action limits (30 and 32 cfu respectively). Viable air limits were also exceeded on 7/14/20 (TNTC). Organisms indicated human, plant, soil, and water origins. The root cause was generally attributed to "failure to follow procedures" without specific supporting data or comprehensive investigation of air patterns or technician actions. Similar issues were noted in INV20025 (fingertip excursion) and five other EM investigations (INV20008, INV2009, INV20011, INV20012, INV20022) in 2020.

2. **Deficient Cleaning and Maintenance Procedures:** Procedures for equipment cleaning and maintenance lack sufficient detail regarding methods, equipment, materials, and disassembly/reassembly.