Form 483

Ridge Properties, LLC Form 483, 2018-03-30

FDA issued a Form 483 to Ridge Properties, LLC on 2018-03-30 with 8 public-safe observations.

483· Form 483 issuedHuman Drugs8 observations

Ridge Properties, LLC · Salem, United States · Issued March 30, 2018

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

30 Mar 2018
21 CFR 211.111

Establishment of time limitations

Cited by Gloria J Baca

30 Mar 2018
21 CFR 211.134(c)

Examinations documented

Cited by Gloria J Baca

30 Mar 2018
21 CFR 211.165(a)

Testing and release for distribution

Cited by Gloria J Baca

30 Mar 2018
21 CFR 211.166(a)

Lack of written stability program

Cited by Gloria J Baca

30 Mar 2018
21 CFR 211.180(e)(2)

Items to cover on annual reviews

Cited by Gloria J Baca

Inspected site

RPRidge Properties, LLCSalem, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.101(d)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.134(c)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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