Atlas

Form 483

Century Systems, Inc. Form 483, 2016-11-15

FDA issued a Form 483 to Century Systems, Inc. on 2016-11-15 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Century Systems, Inc. · Atlanta, United States · Issued November 15, 2016

Overview

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

15 Nov 2016
21 CFR 111.315(d)

Standard reference materials; criteria for selecting

Cited by Larry K Hampton, Tamara J Henderson

15 Nov 2016
21 CFR 111.65

Quality control - quality, dietary supplement

Cited by Larry K Hampton, Tamara J Henderson

15 Nov 2016
21 CFR 111.70(b)(2)

Specifications-component purity, strength, composition

Cited by Larry K Hampton, Tamara J Henderson

15 Nov 2016
21 CFR 111.70(e)

Specifications - identity, purity, strength, composition

Cited by Larry K Hampton, Tamara J Henderson

Inspected site

CSCentury Systems, Inc.Atlanta, United States

Inspection team

LKLarry K Hampton
TJTamara J Henderson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.315(d)Cited across public-safe Form 483 observations1x
21 CFR 111.65Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)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