Blood Bank Computer Systems, Inc
Form 483 issued June 16, 2016 · Auburn, Washington
- Inspection
- Jun 6 – Jun 16, 2016
- Investigators
- James D. Hildreth· Vanessa Y. Jacobs
- Observations
- 3
- Pages
- 4
- FEI number
- 1000221653
In short: On June 16, 2016, FDA issued a Form 483 with 3 observations to Blood Bank Computer Systems, Inc in Auburn, Washington (FEI 1000221653) after an inspection that ran Jun 6 – Jun 16, 2016. The investigators were James D. Hildreth and Vanessa Y. Jacobs. Most observations concern cAPA and management controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action…
- 02
A report of the required information regarding device con'ection and removal actions was not sent to…
- 03
Procedures for training and identifying training needs…
This inspection in context
James D. Hildreth
6 documents · 2011–2016
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Oregon.
The firmBlood Bank Computer Systems, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Blood Bank Computer Systems, Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Blood Bank Computer Systems, Inc?
James D. Hildreth and Vanessa Y. Jacobs are named on this Form 483, for the inspection of Jun 6 – Jun 16, 2016. Each investigator has a profile showing what they cite most.
When was Blood Bank Computer Systems, Inc inspected by FDA?
The inspection ran Jun 6 – Jun 16, 2016, and the Form 483 is dated June 16, 2016.
How do I get the full Form 483 for Blood Bank Computer Systems, Inc?
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.