BSO LLC
Form 483 issued September 20, 2019 · Lakewood, Colorado
- Inspection
- Sep 9 – Sep 20, 2019
- Investigator
- Alan P. Kurtzberg
- Observations
- 2
- Pages
- 1
- FEI number
- 3011976853
In short: On September 20, 2019, FDA issued a Form 483 with 2 observations to BSO LLC in Lakewood, Colorado (FEI 3011976853) after an inspection that ran Sep 9 – Sep 20, 2019. The investigator was Alan P. Kurtzberg. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67(a) (1×) · 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BSO LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected BSO LLC?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Sep 9 – Sep 20, 2019. Each investigator has a profile showing what they cite most.
When was BSO LLC inspected by FDA?
The inspection ran Sep 9 – Sep 20, 2019, and the Form 483 is dated September 20, 2019.
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.