Form 483

DUNCAN REED TRADING CO. Form 483, 2015-05-05

FDA issued a Form 483 to DUNCAN REED TRADING CO. on 2015-05-05 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

DUNCAN REED TRADING CO. · Carrollton, United States · Issued May 5, 2015

Overview

  • 8 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.

5 May 2015
21 CFR 111.103

Written procedures - quality control operations

Cited by Jamie M Bumpas

5 May 2015
21 CFR 111.205(a)

Master manufacturing record - unique formulation

Cited by Jamie M Bumpas

5 May 2015
21 CFR 111.255(a)

Batch record - every batch

Cited by Jamie M Bumpas

5 May 2015
21 CFR 111.55

Production, process controls - implement

Cited by Jamie M Bumpas

5 May 2015
21 CFR 111.103

Written procedures - quality control operations

Cited by Jamie M Bumpas

Inspected site

DRDUNCAN REED TRADING CO.Carrollton, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations2x
21 CFR 111.205(a)Cited across public-safe Form 483 observations2x
21 CFR 111.255(a)Cited across public-safe Form 483 observations2x
21 CFR 111.55Cited across public-safe Form 483 observations2x

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