In Reply to Parent Post by Wes Bucey
I didn't find ANY of the 483s to Utah Medical in first look. Somebody show me the way?
Wes, as far as I know, the 483s are not posted online as are warning letters. The only 483s I've seen are those that companies have posted themselves.
More news today about this today. Statements from 3 of UMD's directors: http://www.utahmed.com/pr/pr081604.htm
They are supporting the fight with FDA.
The September 2001 warning letter is here: http://www.fda.gov/foi/warning_letters/g1989d.pdf
Just some thoughts I had while reading it that are good reminders to all in this business:
*Be sure to capture, trend and evaluate any CAPA activities.
*If you say you're going to fix something, make sure it's fixed. Check it in your internal audits at least once a year, and record that you checked it.
*Document all acceptance activities. Even if it's a simple visual inspection, record what the criteria are, how many are inspected and the results of that inspection.
*Validate processes that cannot be fully verified by subsequent inspection and test. Or, to avoid validation, only perform processes that can be fully verified by subsequent inspection and test.
*Have an explicit procedure for investigations. Document all decision-making involved with each complaint or CAPA activity.
*Be careful with rework. Again, have explicit procedures and document all decision-making.
*If a response involves retraining of individuals, record the training session and audit that the training is being adhered to.
*This is a hard one: if you don't catch deficiencies later recorded by and FDA inspector, it's an indication that the audit system isn't working. Having an outside auditor come in once a year is a good way to make sure some fresh eyes examine your system.
This can avoid the following line in a warning letter: "deficiencies similar to those found in the current inspection were found during the inspection conducted in (whenever)". This never looks good.