FDA Inspection 1130801 — Providence Health And Services Washington
The FDA completed an inspection of Providence Health And Services Washington on Oct 5, 2020 in Tukwila, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 5, 2020
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tukwila, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 21422 | FDCA 503B(b)(2)(A) | Outsourcing facility, compounded drug report follow up |