FDA Inspection 873805 — Philips Respironics, Inc.
The FDA completed an inspection of Philips Respironics, Inc. on Apr 15, 2014 in Murrysville, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 15, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Murrysville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 537 | 21 CFR 820.70(a) | Production processes |