FDA-Inspected Site

BSO LLC

5 FDA inspections are on record for BSO LLC in Lakewood, United States.

483· Form 483 issued

Lakewood, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-07-16.

At a glance

Inspections

5

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
7 Jul 2025 – 16 Jul 2025Human Drugs483View 483 →
25 Jun 2024 – 3 Jul 2024Human Drugs483View 483 →
1 Mar 2021 – 11 Mar 2021Human Drugs483View 483 →
9 Sep 2019 – 20 Sep 2019Human Drugs483View 483 →
25 Aug 2016 – 2 Sep 2016Human Drugs483View 483 →

Observations on record

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

16 Jul 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Lucila B Nwatu

16 Jul 2025
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Lucila B Nwatu

16 Jul 2025
21 CFR 211.165(a)

Testing and release for distribution

Cited by Lucila B Nwatu

16 Jul 2025
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Lucila B Nwatu

16 Jul 2025
21 CFR 211.166(a)(4)

Testing in same container - closure system

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 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.111Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(i)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind BSO LLC's 5 Form 483s

Source PDFs, verbatim observations, 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