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Posts tagged ‘FDA Inspections’

On July 16, 2015, U.S. Food and Drug Administration (FDA) Facility Reviewer Denise DiGuilio presented a seminar titled “What to Expect During a FDA Drug Manufacturing Inspection.”  The seminar was part of a two-day regulatory education event held in Silver Spring, Maryland, USA.  During her presentation, DiGuilio discussed the various types of FDA Current Good […]

According to a January 2015 Food Safety Report published by the United States Government Accountability Office (GAO), the U.S. Food and Drug Administration (FDA) conducted inspections in 48 foreign countries in fiscal year (FY) 2014, with China, Japan, and India subject to the most. FDA told the GAO that foreign inspections are an important part […]

Under the Food and Drug Administration Safety and Innovation Act (FDASIA), the U.S. Food and Drug Administration (FDA) may deem a drug adulterated if that drug is “manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an […]

On October 2, FDA announced on its blog a new data dashboard where users can view data regarding FDA inspections and enforcement.  The dashboard currently contains data for fiscal year (FY) 2009 to FY 2013, and FDA plans to update the database twice a year.  For now, the datasets only include final actions.  Some of […]

On June 6, 2013, the U.S. Food and Drug Administration (FDA) sent a warning letter to Ms. Fina Serra, co-owner and manager of S. Serra Cheese Company in Clinton Township, Michigan.  The letter explained that FDA found excessive levels of E. coli in three finished product samples that were collected during a facility inspection in […]

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