# FDA 483 - BSO LLC - July 03, 2024

Source: https://www.keypedia.com/records/483/bso-llc/63adc541-84fc-4310-8522-65e1a956cf84

> FDA 483 for BSO LLC on July 03, 2024. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BSO LLC
- Inspection Date: 2024-07-03
- Product Type: Biologics
- Office Name: Center for Biologics Evaluation and Research
- Summary: On July 3, 2024, the FDA issued a Form 483 to BSO LLC, an outsourcing facility in Lakewood, CO, following an inspection from June 25 to July 3, 2024. The inspection revealed five observations related to quality system and manufacturing issues.

**Observation 1:** Procedures for preventing microbiological contamination of sterile drug products lacked adequate sterilization process validation. Specifically, sterilization validation studies for pellets (Testosterone, Estradiol, Testosterone/Anastrozole, Progesterone, Testosterone/Cholesterol) were inadequate. The firm could not provide evidence of the material used for dose mapping, making it unclear if the material had similar attenuation and scattering properties to the product. The impact of the sterilization method on product quality was not adequately assessed, with observed post-sterilization potency drops for testosterone and progesterone. Additionally, documentation or scientific justification for sterilization cycles used for Testosterone/Anastrozole pellets was not provided, and samples of Anastrozole 6mg pellets were used instead of Testosterone/Anastrozole pellets in a study where Testosterone/Anastrozole did not meet acceptance criteria. The firm uses irradiation in lieu of sterility testing for product release.

**Observation 2:** Employees lacked adequate training for visual inspection. The Visual Inspection Program's training material for liquid injectables did not include examples of all critical defects (e.g., broken glass, particulate matter, improper crimp), major defects

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- [UNTITLED_LETTER - 2019-01-10](https://www.keypedia.com/records/untitled_letter/bso-llc/1d8a5dbd-2757-4b94-b11f-83a88ef22c1e)
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## Related Officers

- [National Program Expert- Pharmacy Compounding](https://www.keypedia.com/people/lucila-b-nwatu/3d1c9670-8206-425c-bddd-32e395293042)

Company: https://www.keypedia.com/companies/bso-llc/e732cf9c-867d-4a6a-8e36-30374a9a8e4e

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d