According to the Code of Federal Regulations (CFR), 21 CFR 211.125 strict control shall be […]
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The Bi-Monthly Trends Report

Our Bi-monthly GMP Trends Report gives our readers the most frequently cited FDA 483 observations taken from recent FDA Inspections. The non-essential information is redacted to streamline the facts in an easily readable format.

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A company recently received the following observation: ….. The Quality Unit is not involved in […]