Overview
- 6 public-safe observations are available for this inspection.
- 6 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.
11 Mar 2026
21 CFR 820.35(a)
Records for complaints involving failure to meet specifications not maintained
Cited by Jacqueline S Warner
11 Mar 2026
ISO 13485:2016 Clause 4.2.1
QMS documentation does not include required documents
Cited by Jacqueline S Warner
11 Mar 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Jacqueline S Warner
11 Mar 2026
ISO 13485:2016 Clause 7.4.1
Criteria for the evaluation and selection of suppliers not established
Cited by Jacqueline S Warner
Inspected site
AMAllstar Marketing Group LlcHawthorne, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.40(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.35(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.2.1 | 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 7.4.3 | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 6 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