BSO LLC
Form 483 issued July 16, 2025 · Lakewood, Colorado
- Inspection
- Jul 7 – Jul 16, 2025
- Investigator
- Lucila B. Nwatu
- Observations
- 9
- Pages
- 12
- FEI number
- 3011976853
In short: On July 16, 2025, FDA issued a Form 483 with 9 observations to BSO LLC in Lakewood, Colorado (FEI 3011976853) after an inspection that ran Jul 7 – Jul 16, 2025. The investigator was Lucila B. Nwatu. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
Laboratory controls and production account for 6 of 9 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
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 03
Your fum failed to establish adequate written procedures for production and process controls designed to assure…
- 04
The written stability program does not assure testing of the dmg product in the same container-closure…
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
All 6 documents on file for this site, in date order, with what was cited at each inspection.
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 9 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.166 (stability testing). 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 Jul 7 – Jul 16, 2025. Each investigator has a profile showing what they cite most.
When was BSO LLC inspected by FDA?
The inspection ran Jul 7 – Jul 16, 2025, and the Form 483 is dated July 16, 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.