1100411
Respire Medical Holdings, LLC — FEI 3008937561
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 15, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14721 | 21 CFR 820.70(g)(2) | Periodic equipment inspections |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 537 | 21 CFR 820.70(a) | Production processes |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |