Atlas

Form 483

Four In One, LLC Form 483, 2020-02-13

FDA issued a Form 483 to Four In One, LLC on 2020-02-13 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Four In One, LLC · Chelmsford, United States · Issued February 13, 2020

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

13 Feb 2020
21 CFR 114.100(b)

Maintenance of processing and production records

Cited by John P Shelton

13 Feb 2020
21 CFR 117.40(f)

Instruments and Controls

Cited by John P Shelton

13 Feb 2020
21 CFR 117.80(c)

Manufacturing, Processing, Packing, Holding - Controls

Cited by John P Shelton

Inspected site

FIFour In One, LLCChelmsford, United States

Inspection team

JPJohn P Shelton

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 114.100(b)Cited across public-safe Form 483 observations1x
21 CFR 117.40(f)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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