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Form 483

Four In One, LLC Form 483, 2015-07-16

FDA issued a Form 483 to Four In One, LLC on 2015-07-16 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Four In One, LLC · Chelmsford, United States · Issued July 16, 2015

Overview

  • 4 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.

16 Jul 2015
21 CFR 108.35(c)(1)

Registration

Cited by Mark E Farrell

16 Jul 2015
21 CFR 108.35(c)(1)

Registration

Cited by Mark E Farrell

16 Jul 2015
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Mark E Farrell

16 Jul 2015
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Mark E Farrell

Inspected site

FIFour In One, LLCChelmsford, United States

Inspection team

MEMark E Farrell

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.35(c)(1)Cited across public-safe Form 483 observations2x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations2x

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