Atlas

FDA-Inspected Site

Sharn, Inc. dba Sharn Anesthesia, Inc.

4 FDA inspections are on record for Sharn, Inc. dba Sharn Anesthesia, Inc. in Caledonia, United States.

Clean· No action indicated

Caledonia, United States · Last updated July 11, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2015-03-03.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Mar 2015 – 3 Mar 2015Medical Devices & Rad HealthClean
31 Jul 2013Medical Devices & Rad HealthClean
10 Jul 2012Not recorded483View 483 →
11 Aug 2011Not recorded483View 483 →

Observations on record

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

10 Jul 2012
21 CFR 803.17(a)(2)

Lack of System for Determining MDR Events

Cited by Melanie G Warzala

10 Jul 2012
21 CFR 820.22

Quality Audits - defined intervals

Cited by Melanie G Warzala

10 Jul 2012
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Melanie G Warzala

10 Jul 2012
21 CFR 820.90(a)

Nonconforming product control

Cited by Melanie G Warzala

10 Jul 2012
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Melanie G Warzala

Investigators

FDA investigators tied to this site in the record.

Melanie G Warzala2 insp.
Vesa Vuniqi1 insp.
Joshua J Silvestri1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.90(a)Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.181Cited across public-safe Form 483 observations2x
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.198(b)Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.40Cited across public-safe Form 483 observations2x
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 803.17(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.80(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sharn, Inc. dba Sharn Anesthesia, Inc.'s 2 Form 483s

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