Form 483

BSO LLC Form 483, 2021-03-11

FDA issued a Form 483 to BSO LLC on 2021-03-11 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

BSO LLC · Lakewood, United States · Issued March 11, 2021

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

11 Mar 2021
21 CFR 211.192

Written record of investigation incomplete

Cited by Michael A Charles

11 Mar 2021
21 CFR 211.67(b)(3)

Cleaning SOPs/instructions

Cited by Michael A Charles

Inspected site

BLBSO LLCLakewood, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere