FDA-Inspected Site

BSO, LLC

1 FDA inspection is on record for BSO, LLC in Golden, United States.

483· Form 483 issued

Golden, United States · Last updated July 12, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-06-27.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Jun 2025 – 27 Jun 2025Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

27 Jun 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Lucila B Nwatu

27 Jun 2025
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Lucila B Nwatu

27 Jun 2025
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Lucila B Nwatu

27 Jun 2025
21 CFR 211.165(a)

Testing and release for distribution

Cited by Lucila B Nwatu

27 Jun 2025
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Lucila B Nwatu

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind BSO, LLC's 1 Form 483

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat