FDA Inspection 1156266 — Philips Respironics, Inc.
The FDA completed an inspection of Philips Respironics, Inc. on November 9, 2021 in Murrysville, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 9, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Murrysville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |