Form 483

Quality Star Products Ltd. Form 483, 2014-06-30

FDA issued a Form 483 to Quality Star Products Ltd. on 2014-06-30 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Quality Star Products Ltd. · Garland, United States · Issued June 30, 2014

Overview

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

30 Jun 2014
21 CFR 123.6(c)(3)

Critical limits

Cited by Deniza Karacic, Christopher L Jacobs

30 Jun 2014
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Deniza Karacic, Christopher L Jacobs

30 Jun 2014
21 CFR 123.6(c)(6)

Verification procedures - none/frequency

Cited by Deniza Karacic, Christopher L Jacobs

Inspected site

QSQuality Star Products Ltd.Garland, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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