FDA inspections 2008-2015

11. january 2016 at 7:00 | Veronika Valdova, ARETE-ZOE

In the last 7 years, in the period from January 2008 to March 2015, the FDA conducted more than 133,000 inspections. About half of this figure concerned foodborne biological hazards, Food composition, standards and labeling, and food and color additives. About 11,000 of all inspections, or 9%, related to drug quality assurances, and only a tiny fraction (362) identified unapproved and misbranded drugs.

Inspections are classified to reflect the compliance status of a firm. Classifications are based upon findings identified during an inspection and Agency review for compliance.

Bioresearch Monitoring3 298
Blood and Blood Products8 123
Colors and Cosmetics Technology773
Compliance: Devices11 822
Drug Quality Assurance10 902
Food and Color Additives Petition review3 619
Food Composition, Standards, Labeling6 490
Foodborne biological hazards50 370
Human, cellular, tissue and gene therapies3 850
Interagency cooperative activities1
Molecular biology and natural toxins28
Monitoring of marketed animal drugs, feed and devices12 293
Pesticides and chemical concominants4 766
Postmarket assurance: devices6 162
Postmarket surveillance and epidemiology542
Pre-approval evaluation of animal drugs an food additives190
Project evaluation: devices2 225
Unapproved and misbranded drugs362
Vaccines and allergenic products402
Inspection classification database

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