Atlas

FDA-Inspected Site

SCI Medic, Inc.

6 FDA inspections are on record for SCI Medic, Inc. in Frederick, United States.

Clean· No action indicated

Frederick, United States · Last updated July 11, 2026

Overview

  • 6 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-02-23.

At a glance

Inspections

6

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Feb 2023 – 23 Feb 2023Medical Devices & Rad HealthClean
11 Jun 2013 – 14 Jun 2013Medical Devices & Rad Health483View 483 →
13 Oct 2010Not recorded483View 483 →
20 Feb 2008Not recordedClean
30 Nov 2006Not recordedClean
4 Feb 2005Not recordedClean

Observations on record

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

14 Jun 2013
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Joseph A Morkunas

13 Oct 2010
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by James W Leonette, Krista N Flores

13 Oct 2010
21 CFR 820.25(b)

Training records

Cited by James W Leonette, Krista N Flores

13 Oct 2010
21 CFR 820.40

Lack of procedures, or not maintained

Cited by James W Leonette, Krista N Flores

13 Oct 2010
21 CFR 820.50(a)(1)

Documented evaluation

Cited by James W Leonette, Krista N Flores

Investigators

FDA investigators tied to this site in the record.

Jude C Dike1 insp.
Joseph A Morkunas1 insp.
James W Leonette1 insp.
Krista N Flores1 insp.
Tania E Vizcaino1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.70(c)Cited across public-safe Form 483 observations1x
21 CFR 820.70(g)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind SCI Medic, 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