Overview
- 7 public-safe observations are available for this inspection.
- 7 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Apr 2026
ISO 13485:2016 Clause 6.4.1
Work environment requirements and procedures not documented
2 Apr 2026
ISO 13485:2016 Clause 7.5.1
Production controls not adequate
2 Apr 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling records not maintained
2 Apr 2026
ISO 13485:2016 Clause 8.3.1
Records of nonconforming product and actions taken not maintained
2 Apr 2026
ISO 13485:2016 Clause 8.3.2
Nonconforming product concessions accepted without meeting requirements
Inspected site
PDPro-Tech Design & Manufacturing, Inc.Santa Fe Springs, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 6.4.1 | 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 8.2.2 | 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 8.3.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.4 | 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