FDA Inspection 1307052 — Altor Safety
The FDA completed an inspection of Altor Safety on March 12, 2026 in Valley Cottage, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Valley Cottage, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23036 | ISO 13485:2016 Clause 4.2.3 | Medical device file not established and maintained |
| 23136 | ISO 13485:2016 Clause 7.3.10 | Design and development files not maintained |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |