Form 483

Valley Springs Artesian Gold, LLC Form 483, 2011-07-15

FDA issued a Form 483 to Valley Springs Artesian Gold, LLC on 2011-07-15 with 11 public-safe observations.

483· Form 483 issued11 observations

Valley Springs Artesian Gold, LLC · Portage, United States · Issued July 15, 2011

Overview

  • 11 public-safe observations are available for this inspection.
  • 10 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 Jul 2011
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Ivan E Reyes, Justin A Boyd

15 Jul 2011
21 CFR 129.20(a)

Bottling room separation, plant operations

Cited by Ivan E Reyes, Justin A Boyd

15 Jul 2011
21 CFR 129.40(a)(1)

Suitability - equipment, utensils

Cited by Ivan E Reyes, Justin A Boyd

15 Jul 2011
21 CFR 129.80(a)

Effective treatment - product water

Cited by Ivan E Reyes, Justin A Boyd

15 Jul 2011
21 CFR 129.80(a)

Product water samples - Analysis frequency

Cited by Ivan E Reyes, Justin A Boyd

Inspected site

VSValley Springs Artesian Gold, LLCPortage, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 129.80(a)Cited across public-safe Form 483 observations2x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 129.20(a)Cited across public-safe Form 483 observations1x
21 CFR 129.40(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 129.80(d)Cited across public-safe Form 483 observations1x
21 CFR 129.80(e)Cited across public-safe Form 483 observations1x
21 CFR 129.80(g)(1)Cited across public-safe Form 483 observations1x
21 CFR 129.80(g)(2)Cited across public-safe Form 483 observations1x
21 CFR 129.80(g)(3)Cited across public-safe Form 483 observations1x
21 CFR 129.80(h)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 11 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