Navinta, LLCMarch 28, 2019

FDA 483 - Navinta, LLC - March 28, 2019

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Record Details

An FDA inspection of Navinta, LLC's corporate headquarters in Ewing, NJ, revealed a significant documentation deficiency in their postmarketing safety reporting. The firm repeatedly failed to include copies of published scientific articles when submitting 15-day Alert reports based on scientific literature. This indicates a lapse in regulatory submission completeness.

Company: Navinta, LLC
Inspection Date: March 28, 2019
Product Type: Drugs
Office: New Jersey District Office
People: Michael Serrano (investigator)
Mihaela Jason

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ID · 220bccf8-f824-45eb-9607-8652af691d90