Form 483

Blue Chip LLC Form 483, 2010-01-06

FDA issued a Form 483 to Blue Chip LLC on 2010-01-06 with 4 public-safe observations.

483· Form 483 issued4 observations

Blue Chip LLC · Salt Lake City, United States · Issued January 6, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

6 Jan 2010
21 CFR 110.20(b)(1)

Sufficient space

Cited by Neira Acevedo-Ramos

6 Jan 2010
21 CFR 110.20(b)(7)

Screening

Cited by Neira Acevedo-Ramos

6 Jan 2010
21 CFR 110.35(a)

Buildings/good repair

Cited by Neira Acevedo-Ramos

6 Jan 2010
21 CFR 110.35(b)(1)

Safe and adequate for use

Cited by Neira Acevedo-Ramos

Inspected site

BCBlue Chip LLCSalt Lake City, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, 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