FDA Inspection 1307444 — Allstar Marketing Group Llc
The FDA completed an inspection of Allstar Marketing Group Llc on March 11, 2026 in Hawthorne, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hawthorne, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23033 | ISO 13485:2016 Clause 4.2.1 | QMS documentation does not include required documents |
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23151 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities are inadequate |
| 23263 | 21 CFR 820.35(a) | Records for complaints involving failure to meet specifications not maintained |
| 4436 | 21 CFR 803.40(a) | Report of death, injury |