Providence Health and Services
Form 483 issued April 13, 2022 · Tukwila, Washington
- Inspection
- Apr 13, 2022
- Investigator
- Kenneth O. Gee
- Observations
- 1
- Pages
- 3
- FEI number
- 3014577316
In short: On April 13, 2022, FDA issued a Form 483 with 1 observation to Providence Health and Services in Tukwila, Washington (FEI 3014577316) after an inspection that ran Apr 13, 2022. The investigator was Kenneth O. Gee. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The flow of components, diug product containers, closures and in-process materials through the building is not…
This inspection in context
Kenneth O. Gee
9 documents · 2017–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmProvidence Health and Services history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Providence Health and Services?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Providence Health and Services?
Kenneth O. Gee is named on this Form 483, for the inspection of Apr 13, 2022. Each investigator has a profile showing what they cite most.
When was Providence Health and Services inspected by FDA?
The inspection ran Apr 13, 2022, and the Form 483 is dated April 13, 2022.
How do I get the full Form 483 for Providence Health and Services?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.