FDA Inspection 1115031 — PatCen Healthcare Inc.
The FDA completed an inspection of PatCen Healthcare Inc. on Jan 14, 2020 in Bellevue, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 14, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bellevue, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |