Atlas

Form 483

Avadim Holdings Inc Form 483, 2009-03-31

FDA issued a Form 483 to Avadim Holdings Inc on 2009-03-31 with 4 public-safe observations.

483· Form 483 issued4 observations

Avadim Holdings Inc · Swannanoa, United States · Issued March 31, 2009

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

31 Mar 2009
21 CFR 211.22(c)

Approve or reject procedures or specs

Cited by Edward Deberry

31 Mar 2009
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Edward Deberry

31 Mar 2009
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Edward Deberry

31 Mar 2009
21 CFR 211.166(a)

Lack of written stability program

Cited by Edward Deberry

Inspected site

AHAvadim Holdings IncSwannanoa, United States

Inspection team

EDEdward Deberry

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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