Tag Archives: inspections

FDA Releases Partial FY 2016 Inspection Classifications


Classifications for FDA inspections during the first half of FY 2016 (Oct 2015 thru March 2016) were released by FDA a few weeks back.  The above chart shows inspection outcomes under CFSAN (which includes foods and dietary supplements). The number of 483s issued in the area of “Food Composition, Standards, Labeling and Economics” continues to decline slightly — just short of 60% of inspections in that area now result in no 483 being issued. Most DS inspections occur in that project area, along with “Foodborne Biological Hazards” (which also applies to regular food facilities.) See more by clicking on the chart.

SupplySide West Workshop: Evaluating and Partnering with Contract Labs


I will be speaking along with 3 other presenters at this workshop on

Wednesday, October 05, 1:30 PM – 4:30 PM

Laboratory testing of ingredients and finished goods is top-of-mind in the natural products industry. Beyond the media coverage of testing methods lie a host of concerns from qualifying and selecting an appropriate laboratory partner to method validation, audits and supply chain integrity. Explore the current state of affairs and join the discussion around how appropriate testing and information sharing throughout the product development process is critical to efficacy and safety.

  • What should a laboratory audit entail and can a lab meet specific testing needs
  • The GMP testing requirements and their impact on manufacturers and marketers
  • Supply chain management and the role of testing throughout the chain

See http://west.supplysideshow.com/schedule/#/viewEvent/bb49164ebdcc410ea9b41585fb26bfa4/wrk/day/-1

FDA releases updated Inspection Classifications for FY 2015


For those of you who track this stuff, FDA just released new inspections classifications data that can be found at: http://www.fda.gov/ICECI/Inspections/ucm222557.htm

The above chart shows FY2015 inspection classifications in all CFSAN project areas (foods, cosmetics, dietary supplements) and their outcomes  (OAI – Official Action Indicated; VAI – Voluntary Action Indicated; NAI – No Action Indicated)  OAI and VAI means that a 483 was issued in a particular project area, NAI means basically a clean inspection.