FDA Inspection 1324524 — AIRGLE CORPORATION
The FDA completed an inspection of AIRGLE CORPORATION on Jun 30, 2026 in Holbrook, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 30, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Holbrook, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23136 | ISO 13485:2016 Clause 7.3.10 | Design and development files not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |