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Jan 11, 2014 ... i) Raw material I'm: batch ii WI was analyzed for Chromatographic Purity via GC as ..... from employees involved in GMP, GCP, GLP and or R&D activities .... D) During our review of
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What is fda form 483?
Fda form 483 is a form used by the U.S. Food and Drug Administration (FDA) to document and communicate observations of non-compliance found during an inspection.
Who is required to file fda form 483?
Companies in the pharmaceutical or medical device industry that are inspected by the FDA are required to file fda form 483 if any non-compliance issues are found.
How to fill out fda form 483?
Fda form 483 is typically completed by FDA inspectors during an inspection, but the company being inspected may also provide additional information or responses to the observations included in the form.
What is the purpose of fda form 483?
The purpose of fda form 483 is to document observations of non-compliance found during an FDA inspection and to communicate these findings to the company being inspected.
What information must be reported on fda form 483?
Fda form 483 typically includes information about the observations of non-compliance found during an FDA inspection, as well as any responses or corrective actions taken by the company being inspected.
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