BSO LLC
Form 483 issued June 25, 2024 · Lakewood, Colorado
- Inspection
- Jun 25, 2024
- Investigator
- Lucila B. Nwatu
- Observations
- 4
- Pages
- 7
- FEI number
- 3011976853
In short: On June 25, 2024, FDA issued a Form 483 with 4 observations to BSO LLC in Lakewood, Colorado (FEI 3011976853) after an inspection that ran Jun 25, 2024. The investigator was Lucila B. Nwatu. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 4 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
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
EMPI.OYEE(S) SIGNATURE There is a failure to thoroughly review any unexplained discrepancy whether or not the…
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 4 observations on this Form 483, mostly about production and quality system. 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 25, 2024. Each investigator has a profile showing what they cite most.
When was BSO LLC inspected by FDA?
The inspection ran Jun 25, 2024, and the Form 483 is dated June 25, 2024.
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.