Overview
- 14 public-safe observations are available for this inspection.
- 7 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.
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
Inspected site
UOUnik Orthopedics, IncSan Jose, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 5.6.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.5.8 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 14 observations
The source PDF, 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