FDA Inspection 1130801 — Providence Health and Services Washington Dba Providence Infusion Hospital Services
The FDA completed an inspection of Providence Health and Services Washington Dba Providence Infusion Hospital Services on October 5, 2020 in Tukwila, WA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 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 |