Form 483

Ridge Properties, LLC Form 483, 2017-03-16

FDA issued a Form 483 to Ridge Properties, LLC on 2017-03-16 with 55 public-safe observations.

483· Form 483 issuedHuman Drugs55 observations

Ridge Properties, LLC · Salem, United States · Issued March 16, 2017

Overview

  • 55 public-safe observations are available for this inspection.
  • 11 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.

16 Mar 2017
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Gloria J Baca

16 Mar 2017
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Gloria J Baca

16 Mar 2017
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Gloria J Baca

16 Mar 2017
21 CFR 211.130

Procedures are written, and followed

Cited by Gloria J Baca

16 Mar 2017
21 CFR 211.130

Procedures are written, and followed

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 211.100(a)Cited across public-safe Form 483 observations5x
21 CFR 211.130Cited across public-safe Form 483 observations5x
21 CFR 211.150(b)Cited across public-safe Form 483 observations5x
21 CFR 211.165(a)Cited across public-safe Form 483 observations5x
21 CFR 211.166(a)Cited across public-safe Form 483 observations5x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations5x
21 CFR 211.188Cited across public-safe Form 483 observations5x
21 CFR 211.198(a)Cited across public-safe Form 483 observations5x
21 CFR 211.22(a)Cited across public-safe Form 483 observations5x
21 CFR 211.25(a)Cited across public-safe Form 483 observations5x
21 CFR 211.80(d)Cited across public-safe Form 483 observations5x

Full 483 report

Get the verbatim text of all 55 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