BSO LLC
FDA 503B outsourcing facility
Lakewood, Colorado
Key Takeaways
- FDA-registered 503B outsourcing facility since 2024
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: June 27, 2025
- 5 FDA drug recalls on record (2025)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- January 24, 2024
- Most recent registration
- November 25, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- June 27, 2025
The FDA last inspected BSO LLC on June 27, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. The FDA has not yet determined whether further action will be taken.
FDA recall history
BSO LLC has 5 FDA drug recalls on record in 2025, based on the FDA enforcement database. Breakdown: 5 Class II.
Recall reasons on record include presence of particulate matter: glass particles were found in pellet vials.
| Date | Class | Product | Reason |
|---|---|---|---|
| April 2025 | Class II | TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office | Presence of Particulate Matter: Glass particles were found in pellet vials. |
| April 2025 | Class II | TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Se | Presence of Particulate Matter: Glass particles were found in pellet vials. |
| April 2025 | Class II | TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office | Presence of Particulate Matter: Glass particles were found in pellet vials. |
| April 2025 | Class II | TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or O | Presence of Particulate Matter: Glass particles were found in pellet vials. |
| April 2025 | Class II | TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office | Presence of Particulate Matter: Glass particles were found in pellet vials. |
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
What this facility compounds
BSO LLC reports compounding 6 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- Anastrozole
- Anastrozole; Testosterone Cypionate
- Estradiol
- Prasterone; Testosterone Cypionate
- Progesterone
- Testosterone
Location
12860 W Cedar Dr Ste 211, N/A, Lakewood, CO 80228-1971
Satellite and street imagery via Esri. Open larger map.
Contact
FDA-registered contact: Michelle Violi Ext 1113, 608-221-7800. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of BSO LLC with the Colorado State Board of Pharmacy.
503B facilities in Colorado
BSO LLC also operates a registered 503B facility at Golden, CO.
Colorado has 4 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Colorado.
Frequently asked questions
Is BSO LLC registered with the FDA?
Yes. BSO LLC is a registered 503B outsourcing facility, first registered with the FDA on January 24, 2024 and most recently registered on November 25, 2025.
Has BSO LLC been inspected by the FDA?
The FDA last inspected BSO LLC on June 27, 2025. A Form FDA 483 was issued.
Has BSO LLC had any FDA drug recalls?
BSO LLC has 5 FDA drug recalls on record (2025) in the FDA enforcement database.
What does BSO LLC compound?
BSO LLC reports compounding 6 active ingredients to the FDA.
Where is BSO LLC located?
BSO LLC is located in Lakewood, Colorado (12860 W Cedar Dr Ste 211).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by BSO LLC. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.