Form 483

Green Hope LLC dba Rosewood Products Form 483, 2012-10-19

FDA issued a Form 483 to Green Hope LLC dba Rosewood Products on 2012-10-19 with 3 public-safe observations.

483· Form 483 issued3 observations

Green Hope LLC dba Rosewood Products · Ann Arbor, United States · Issued October 19, 2012

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.

19 Oct 2012
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Marlon K Turner, Vesa Vuniqi

19 Oct 2012
21 CFR 110.37(b)(5)

Backflow prevention

Cited by Marlon K Turner, Vesa Vuniqi

19 Oct 2012
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Marlon K Turner, Vesa Vuniqi

Inspected site

GHGreen Hope LLC dba Rosewood ProductsAnn Arbor, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)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