Form 483

Valley Gem Inc. - Valley Gem Form 483, 2019-07-10

FDA issued a Form 483 to Valley Gem Inc. - Valley Gem on 2019-07-10 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Valley Gem Inc. - Valley Gem · Marietta, United States · Issued July 10, 2019

Overview

  • 5 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.

10 Jul 2019
21 CFR 1250.28

Handling to avoid contamination

Cited by Alan Escalona, Andrew M Kupper

10 Jul 2019
21 CFR 1250.33(a)

Adequate facilities for cleaning, bactericidal treatment

Cited by Alan Escalona, Andrew M Kupper

10 Jul 2019
21 CFR 1250.33(a)

Maintained in good repair

Cited by Alan Escalona, Andrew M Kupper

10 Jul 2019
21 CFR 1250.34

Thermometers

Cited by Alan Escalona, Andrew M Kupper

10 Jul 2019
21 CFR 1250.82(d)

Identification marks on tanks and piping

Cited by Alan Escalona, Andrew M Kupper

Inspected site

VGValley Gem Inc. - Valley GemMarietta, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1250.33(a)Cited across public-safe Form 483 observations2x
21 CFR 1250.28Cited across public-safe Form 483 observations1x
21 CFR 1250.34Cited across public-safe Form 483 observations1x
21 CFR 1250.82(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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