March 18th, 2013 · No Comments · Uncategorized
Laclede, Inc. received a Warning Letter from FDA outlining three cGMP violations as well as Unapproved New Drug and Misbranding violations. Here’s one cGMP violation:
“Your firm failed to conduct at least one specific identity test on a component when relying on that component supplier’s analysis, and failed to establish the reliability of the component supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals. 21 CFR § 211.84(d)(2)”
Read the Warning Letter. Go to: www.gmptrainingsystems.com/resources
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