FDA Inspection 1091789 — Philips Medical Systems (Cleveland) Inc
The FDA completed an inspection of Philips Medical Systems (Cleveland) Inc on June 4, 2019 in Cleveland, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 4, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cleveland, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3696 | 21 CFR 820.100(b) | Documentation |