FDA Releases GMP Inspection Observations Data

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Silver Spring, MD—In late January, the U.S. Food and Drug Administration (FDA) released its Inspectional Observation Summaries for fiscal year (FY) 2015. 

Of the 4,850 total 483’s issued in FY 2015 (and for which data was available), the most were issued to food manufacturers (2,300) and drug makers (1,008). Within the food 483, the most frequent citations were

  • Lack of effective pest exclusion (320 times)
  • Lack of sanitation monitoring (279 times)
  • Failure to screen for pests (202 times)
  • HACCP plan not in place (190 times)
  • Floors, walls and ceilings in the plant were not constructed for adequate cleaning and repair (167 times)
  • Importer verification was not properly recorded or performed (163 times)

Compared with FY 2014 data, food manufacturers had fewer 483s this year (2,300 in 2015 versus 2,476 in 2014), but drug companies had more (1,008 in 2015 versus 645 in 2014).

Published on WholeFoods Magazine Online 3/9/2016