Overview
- 5 public-safe observations are available for this inspection.
- 5 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.
10 Apr 2026
21 CFR 803.17
Lack of Written MDR Procedures
Cited by Brittany D Mccracken, Sasha L Eckstein
10 Apr 2026
ISO 13485:2016 Clause 5.6.1
Management review records not maintained
Cited by Brittany D Mccracken, Sasha L Eckstein
10 Apr 2026
ISO 13485:2016 Clause 6.2
Process(es) for personnel competence, training and awareness not documented
Cited by Brittany D Mccracken, Sasha L Eckstein
10 Apr 2026
ISO 13485:2016 Clause 8.3.1
Procedure for nonconforming product not documented
Cited by Brittany D Mccracken, Sasha L Eckstein
10 Apr 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Brittany D Mccracken, Sasha L Eckstein
Inspected site
AQAll Quality & Services, Inc.Fremont, United States
Inspection team
SLSasha L Eckstein
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.6.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.2 | 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 8.5.2 | 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