GMP Tips

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Ineffective Line Clearance cited by FDA in Warning Letter

June 28th, 2010 · No Comments · Uncategorized

FDA discovered tablets left from previous runs in packaging and labeling equipment. This is among several violations listed in a Warning Letter issued to L. Perrigo Company by FDA. They also shipped tablets contaminated with metal shavings.


Read Warning Letters like this one to see what FDA considers important and how FDA interprets the words in the GMP regulations like “adequate,” “as necessary,” “appropriate,” and other “weasel words.” Go to:
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