Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
2 Jun 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Felicia E Armbrustmacher
2 Jun 2026
ISO 13485:2016 Clause 7.3.8
Design and development transfer procedures not documented
Cited by Felicia E Armbrustmacher
2 Jun 2026
ISO 13485:2016 Clause 7.4.1
Criteria for the evaluation and selection of suppliers not established
Cited by Felicia E Armbrustmacher
2 Jun 2026
ISO 13485:2016 Clause 7.5.6
Planned results not consistently met during validation of processes
Cited by Felicia E Armbrustmacher
2 Jun 2026
ISO 13485:2016 Clause 8.3.1
Procedure for nonconforming product not documented
Cited by Felicia E Armbrustmacher
Inspected site
GMGuardian Medical USA Inc.Swanton, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.8 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 observations
The full inspection record, as Atlas holds it, 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