BSO LLC
Form 483 issued September 2, 2020 · Lakewood, Colorado
- Inspection
- Aug 25, 2016 – Sep 2, 2020
- Investigators
- Zachary A. Bogorad· Zachary L. Stamm
- Observations
- 2
- Pages
- 2
- FEI number
- 3011976853
In short: On September 2, 2020, FDA issued a Form 483 with 2 observations to BSO LLC in Lakewood, Colorado (FEI 3011976853) after an inspection that ran Aug 25, 2016 – Sep 2, 2020. The investigators were Zachary A. Bogorad and Zachary L. Stamm. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.111 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Time limits are not established when appropriate for the completion of each production phase to assure…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Zachary A. Bogorad
12 documents · 2011–2020
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
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 211.111
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 production. 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?
Zachary A. Bogorad and Zachary L. Stamm are named on this Form 483, for the inspection of Aug 25, 2016 – Sep 2, 2020. Each investigator has a profile showing what they cite most.
When was BSO LLC inspected by FDA?
The inspection ran Aug 25, 2016 – Sep 2, 2020, and the Form 483 is dated September 2, 2020.
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.