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No procedures in place for the analytical lab to forward OOS results to xxxx in a timely manner.I have always been a big believer in having kids respond to reading--thoughtful, defensible, evidence-based responses.Most useful is to have the 483, the EIR, and the warning letter from the same inspection.When thoroughly read this information is ideal to prepare firms for inspections.
I blogged about these cards on my other blog, Teaching With a Mountain View, and when I did that, I typed them up so that I could share them (You can get them FREE here! I love to see where student thinking is with these!
Neither your firm, nor xxxx had clearly assumed the responsibilities of a quality control unit for such critical functions as in-process review testing, review prior to product release, review of third party laboratory results, and initiation o investigation into out-of-specification (00S) results.