# FDA 483 - BSO LLC - September 20, 2019

Source: https://www.keypedia.com/records/483/bso-llc/6273f8f8-8960-4f69-8570-2c516e1594da

> FDA 483 for BSO LLC on September 20, 2019. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BSO LLC
- Inspection Date: 2019-09-20
- Product Type: Drugs
- Office Name: Denver District Office
- Summary: This FDA Form 483 was issued to BSO LLC dba Belmar Select Outsourcing, an outsourcing facility located at 12860 W Cedar Dr Ste 211, Lakewood, CO 80228-1971. The inspection was conducted from September 9, 2019, to September 20, 2019, and the amended 483 was issued on September 20, 2019. Anne Szilagyi, General Manager/VP of Quality, was the individual to whom the report was issued.

Two observations were made during the inspection:

1.  **Equipment and utensil cleaning:** Equipment and utensils are not cleaned at appropriate intervals to prevent contamination. Specifically, validation/verification of cleaning methods for tools and equipment used in the manufacture of pellet drug products has not been proven. Data for cleaning from testosterone/cholesterol pellets and progesterone pellets had inappropriate acceptance criteria.

2.  **Microbiological contamination prevention procedures:** Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
    *   An employee in the blending/granulation room (ISO 8) of the cleanroom was observed on September 9, 2019, with a beard cover that did not completely cover the beard.
    *   On the same day, an inverted umbrella was observed on a plastic tray in an unclassified

## Related Documents

- [483 - 2021-03-11](https://www.keypedia.com/records/483/bso-llc/f198ba73-7271-43ba-a181-826614e28395)
- [145 - 2020-06-22](https://www.keypedia.com/records/145/bso-llc/60079365-e139-4ecc-a6af-abbdf9f5fd9d)
- [483 - 2024-07-03](https://www.keypedia.com/records/483/bso-llc/63adc541-84fc-4310-8522-65e1a956cf84)
- [UNTITLED_LETTER - 2019-01-10](https://www.keypedia.com/records/untitled_letter/bso-llc/1d8a5dbd-2757-4b94-b11f-83a88ef22c1e)
- [483 - 2021-03-11](https://www.keypedia.com/records/483/bso-llc/7521253e-ee13-46ba-83d4-ff4352a29f1d)

## Related Officers

- [Consumer Safety Officer (Drug Specialist)](https://www.keypedia.com/people/alan-p-kurtzberg/36ee316e-6d19-44b2-a131-fc254ada4f41)

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

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face