Atlas

FDA-Inspected Site

Unik Orthopedics, Inc

2 FDA inspections are on record for Unik Orthopedics, Inc in San Jose, United States.

483· Form 483 issued

San Jose, United States · Last updated July 11, 2026

Overview

  • 2 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-03-13.

At a glance

Inspections

2

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Mar 2026 – 13 Mar 2026Medical Devices & Rad Health483View 483 →
24 Oct 2022 – 25 Oct 2022Medical Devices & Rad HealthClean

Observations on record

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

13 Mar 2026
ISO 13485:2016 Clause 5.6.1

QMS not reviewed by top management at documented planned intervals

Cited by Kenya Destin

13 Mar 2026
ISO 13485:2016 Clause 5.6.1

QMS not reviewed by top management at documented planned intervals

Cited by Kenya Destin

13 Mar 2026
ISO 13485:2016 Clause 7.1

Product realization risk management processes not documented

Cited by Kenya Destin

13 Mar 2026
ISO 13485:2016 Clause 7.1

Product realization risk management processes not documented

Cited by Kenya Destin

13 Mar 2026
ISO 13485:2016 Clause 7.4.1

Procedures for purchasing process not documented

Cited by Kenya Destin

Investigators

FDA investigators tied to this site in the record.

Kenya Destin1 insp.
Mary R Hole1 insp.
Elizabeth A Dakan1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 5.6.1Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 7.4.1Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 7.5.8Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 8.2.2Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 8.2.4Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Unik Orthopedics, Inc's 1 Form 483

Source PDFs 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