Form 483

Blue Chip LLC Form 483, 2015-09-09

FDA issued a Form 483 to Blue Chip LLC on 2015-09-09 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Blue Chip LLC · Salt Lake City, United States · Issued September 9, 2015

Overview

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

Inspectional observations

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

9 Sep 2015
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Christina A Mayer, Justin H Erickson

9 Sep 2015
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by Christina A Mayer, Justin H Erickson

9 Sep 2015
21 CFR 110.20(b)(1)

Sufficient space

Cited by Christina A Mayer, Justin H Erickson

9 Sep 2015
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Christina A Mayer, Justin H Erickson

9 Sep 2015
21 CFR 110.20(b)(7)

Screening

Cited by Christina A Mayer, Justin H Erickson

Inspected site

BCBlue Chip LLCSalt Lake City, United States

Inspection team

CAChristina A Mayer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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