Overview
- 9 public-safe observations are available for this inspection.
- 9 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.
17 Feb 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Rosanna M Goodrich
17 Feb 2026
ISO 13485:2016 Clause 4.2.2
Specific requirements of the Quality Manual not documented
Cited by Rosanna M Goodrich
17 Feb 2026
ISO 13485:2016 Clause 5.5.1
Management responsibilities and authorities not documented
Cited by Rosanna M Goodrich
17 Feb 2026
ISO 13485:2016 Clause 7.2.2
Required actions not taken when product requirements changed
Cited by Rosanna M Goodrich
17 Feb 2026
ISO 13485:2016 Clause 7.4.1
Records of supplier (re)evaluation, selection, and monitoring not maintained
Cited by Rosanna M Goodrich
Inspected site
MLMirac LLCDayton, 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 4.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.5.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.2.2 | 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 8.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.3.1 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 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