Top 10 FDA 483 Citations Linked to Poor SOP Documentation
Top 10 FDA 483 Citations Linked to Poor SOP Documentation Most Frequent FDA 483 SOP Violations and How to Avoid Them One of the leading causes of FDA 483 citations in pharmaceutical manufacturing is poor or inadequate Standard Operating Procedure (SOP) documentation. During inspections, the FDA places great emphasis on how well written, maintained, and…
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