FDA-Inspected Site

Avadim Holdings Inc

4 FDA inspections are on record for Avadim Holdings Inc in Swannanoa, United States.

483· Form 483 issued

Swannanoa, United States · Last updated August 15, 2026

Overview

  • 4 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-05-22.

At a glance

Inspections

4

Form 483s

3

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
19 May 2025 – 22 May 2025Human Drugs483View 483 →
4 Mar 2019 – 6 Mar 2019Human DrugsClean
1 Nov 2016 – 4 Nov 2016Human Drugs483On file
31 Mar 2009Not recorded483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

22 May 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Dorothy P Kramer

22 May 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Dorothy P Kramer

22 May 2025
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Dorothy P Kramer

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

Investigators

FDA investigators tied to this site in the record.

Constance Y Fears1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Avadim Holdings Inc's 3 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat