Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
1 Apr 2026
ISO 13485:2016 Clause 4.2.5
Procedures for control of records not documented
Cited by Shannon A Gregory
1 Apr 2026
ISO 13485:2016 Clause 7.3.9
Requirements for design and development changes not met before implementation
Cited by Shannon A Gregory
1 Apr 2026
ISO 13485:2016 Clause 7.5.6
Process for production and service provision not validated
Cited by Shannon A Gregory
1 Apr 2026
ISO 13485:2016 Clause 8.3.1
Records of nonconforming product and actions taken not maintained
Cited by Shannon A Gregory
Inspected site
MIMidwest-Tek, Inc.New Albany, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 4.2.5 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.1 | 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 |
Full 483 report
Get the verbatim text of all 5 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