BSO LLC
FDA inspection history across 2 sites, 2019 to 2025
- 5
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2019: one Form 483 and one warning letter; 2020: one Form 483; 2021: one Form 483; 2024: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Three Form 483s and one warning letter, at Lakewood, Colorado and Colorado.
- 2024–25Two Form 483s, at Lakewood, Colorado.
- 2025The longest 483 on file: 9 observations over 12 pages at Lakewood, Colorado.
Cited most
Across all BSO observations on file
- 21 CFR 211.113(b)Control of microbiological contamination3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.111Time limitations on production2
- 21 CFR 211.166(a)(3)Stability testing2
- 21 CFR 211.192Production record review2
The complete BSO file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Lakewood, Colorado
Five Form 483s · 2019 to 2025 · 21 observations
Latest: Form 483, Jul 16, 2025 →Colorado
One warning letter · 2019
Latest: Warning letter, Jan 10, 2019 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-16 | 483 Form 483 | Lakewood, Colorado | 9 | $99 |
| 2024-06-25 | 483 Form 483 | Lakewood, Colorado | 4 | $99 |
| 2021-03-11 | 483 Form 483 | Lakewood, Colorado | 4 | $99 |
| 2020-09-02 | 483 Form 483 | Lakewood, Colorado | 2 | $99 |
| 2019-09-20 | 483 Form 483 | Lakewood, Colorado | 2 | $99 |
| 2019-01-10 | Warning letter Warning letter | Colorado | — | $99 |
Investigators on these documents
Lucila B. Nwatu (2)Alan P. Kurtzberg (1)Michael A. Charles (1)Zachary A. Bogorad (1)Zachary L. Stamm (1)
FEI number 3011976853 · most recent document Jul 16, 2025
About BSO LLC
How many FDA Form 483s has BSO LLC received?
FDA Intel has 5 Form 483s on file for BSO LLC; the most recent is dated Jul 16, 2025.
When was BSO LLC last inspected by FDA?
The most recent FDA inspection document on file for BSO LLC is a Form 483 dated Jul 16, 2025, for the site in Lakewood, Colorado.
What did FDA cite at BSO LLC?
The regulations cited most in the observations on file for BSO LLC are 21 CFR 211.113(b) (Control of microbiological contamination), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.111 (Time limitations on production), 2 times.
Has BSO LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for BSO LLC; the most recent is dated Jan 10, 2019.