# FDA 483 - BSO LLC - March 11, 2021

Source: https://www.globalkeysolutions.net/records/483/bso-llc/7521253e-ee13-46ba-83d4-ff4352a29f1d

> FDA 483 for BSO LLC on March 11, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BSO LLC
- Inspection Date: 2021-03-11
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of BSO LLC, an outsourcing facility in Lakewood, CO, revealed significant deficiencies across multiple operational areas. The firm failed to conduct thorough investigations into environmental monitoring excursions and lacked adequately detailed procedures for equipment cleaning and maintenance. Additionally, drug product labels were found to be missing required ingredient information, and the facility was compounding drugs that are essentially copies of approved drugs.

## Related Documents

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- [UNTITLED_LETTER - 2019-01-10](https://www.globalkeysolutions.net/records/untitled_letter/bso-llc/1d8a5dbd-2757-4b94-b11f-83a88ef22c1e)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-a-charles/f83241f0-ae3b-4535-ac03-e790bbf666ca)

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

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