FDA Inspection 1149323 — Philips North America LLC
The FDA completed an inspection of Philips North America LLC on Aug 20, 2021 in Bothell, 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 20, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bothell, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3224 | 21 CFR 820.70(g)(2) | Periodic equipment inspection lack of or inadequate procedu |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |