FDA Inspection 1182077 — Respire Medical Holdings, LLC
The FDA completed an inspection of Respire Medical Holdings, LLC on October 25, 2022 in Brooklyn, 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
- October 25, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3837 | 21 CFR 820.25(b) | Training records |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |