Bloodworks
Form 483 issued May 3, 2024 · Seattle, Washington
- Inspection
- Apr 22 – May 3, 2024
- Investigators
- Kaarin M. Slotte· Sunitha K. Rajaram
- Observations
- 1
- Pages
- 3
- FEI number
- 3071347
In short: On May 3, 2024, FDA issued a Form 483 with 1 observation to Bloodworks in Seattle, Washington (FEI 3071347) after an inspection that ran Apr 22 – May 3, 2024. The investigators were Kaarin M. Slotte and Sunitha K. Rajaram. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84(d)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Drug product component testing is deficient in that at least one specific test to verify the…
This inspection in context
Kaarin M. Slotte
1 document · 2024
Cites 211.84(d)(1) (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in Washington.
The firmBloodworks history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bloodworks?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Bloodworks?
Kaarin M. Slotte and Sunitha K. Rajaram are named on this Form 483, for the inspection of Apr 22 – May 3, 2024. Each investigator has a profile showing what they cite most.
When was Bloodworks inspected by FDA?
The inspection ran Apr 22 – May 3, 2024, and the Form 483 is dated May 3, 2024.
How do I get the full Form 483 for Bloodworks?
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.