BSO, LLC
Form 483 issued June 27, 2025 · Go lden, Colorado
- Inspection
- Jun 16 – Jun 27, 2025
- Investigator
- Lucila B. Nwatu
- Observations
- 8
- Pages
- 11
- FEI number
- 3030548360
In short: On June 27, 2025, FDA issued a Form 483 with 8 observations to BSO, LLC in Go lden, Colorado (FEI 3030548360) after an inspection that ran Jun 16 – Jun 27, 2025. The investigator was Lucila B. Nwatu. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
The written stability program for drug products does not…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Lucila B. Nwatu
18 documents · 2015–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmBSO, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BSO, LLC?
FDA listed 8 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected BSO, LLC?
Lucila B. Nwatu is named on this Form 483, for the inspection of Jun 16 – Jun 27, 2025. Each investigator has a profile showing what they cite most.
When was BSO, LLC inspected by FDA?
The inspection ran Jun 16 – Jun 27, 2025, and the Form 483 is dated June 27, 2025.
How do I get the full Form 483 for BSO, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.