FDA 483 - BSO LLC - September 20, 2019

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