BSO LLC
Form 483 issued March 11, 2021 · Lakewood, Colorado
- Inspection
- Mar 1 – Mar 11, 2021
- Investigator
- Michael A. Charles
- Observations
- 4
- Pages
- 6
- FEI number
- 3011976853
In short: On March 11, 2021, FDA issued a Form 483 with 4 observations to BSO LLC in Lakewood, Colorado (FEI 3011976853) after an inspection that ran Mar 1 – Mar 11, 2021. The investigator was Michael A. Charles. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 3 systems, led by quality system.
Most cited: 21 CFR 211.192 (1×) · 211.67(b)(3) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) 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 211.192
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 quality system, facilities & equipment and packaging & labeling. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected BSO LLC?
Michael A. Charles is named on this Form 483, for the inspection of Mar 1 – Mar 11, 2021. Each investigator has a profile showing what they cite most.
When was BSO LLC inspected by FDA?
The inspection ran Mar 1 – Mar 11, 2021, and the Form 483 is dated March 11, 2021.
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.