'We are concerned about your firm's fundamental understanding'

Phrase: "We are concerned about your firm's fundamental understanding"
From: Warning letter 10-ATL-15 to River's Edge Pharmaceuticals

In this warning, the regulator's concern is whether the River's Edge quality control unit understands what's expected of it. Another concern is whether the drugmakers understands the FDA expectations of a company that enters into agreements with contract manufacturers.

Summary

'We are concerned about your firm's fundamental understanding'
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