Overview
- 7 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.
25 Jun 2026
ISO 13485:2016 Clause 5.1
Lack of evidence for top management's commitment to QMS
Cited by Linda Galindo
25 Jun 2026
ISO 13485:2016 Clause 7.1
Processes needed for product realization not planned and developed
Cited by Linda Galindo
25 Jun 2026
ISO 13485:2016 Clause 7.4.1
Procedures for purchasing process not documented
Cited by Linda Galindo
25 Jun 2026
ISO 13485:2016 Clause 7.5.6
Process for production and service provision not validated
Cited by Linda Galindo
Inspected site
AMALIEN MILLING TECHNOLOGIESGlendora, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 4.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | 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 7 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