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# CDER Inspections Focusing on Compounders: Consultant
- URL: https://www.fdaweb.com/cder-inspections-focusing-on-compounders-consultant/
- Published: 2016-02-23T12:00:00.000Z
- Updated: 2026-09-15T02:38:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134857

> Unger Consulting principal **Barbara Unger** says that there has been a CDER enforcement focus on compounding pharmacies between FY 2013 and FY 2015, at the possible expense of other U.S. and outside-U.S. pharma sites. She also finds that inspection observations did not change significantly between FY 2013 and FY 2015, despite slight increases in the frequency of some observations. [Analyzing](http://ungerconsulting.net/wp-content/uploads/2016/02/FINAL-FY-2015-CDER-INSPECTION-OBSERVATIONS-and-WARNING-LETTER-DATA.pdf?ref=fdaweb.com) metrics publicly available through FDA, Unger says that the slight increases may represent the increased focus on compounding pharmacies and outsourcing facilities, although data are not available to verify that is the cause.  
>  
> She finds that drug good manufacturing practice Warning Letters issued to compounding pharmacies increased dramatically from FY 2013 to FY 2014 and 2015\. “This represents an unusual enforcement focus on a single segment of the drug industry,” she writes. While FDA Office of Regulatory Affairs statistics show that some 3% of inspections result in Warning Letters, for compounding pharmacies the total is closer to 40%.  
>  
> She reports that the number of Warning Letters issued to non-compounding pharmacy sites in the U.S. decreased dramatically during the period and the number of Warning Letters issued to sites outside the U.S. also has decreased since FY 2013\. “Enforcement focus seems to be sharply focused on compounding pharmacies at the possible expense of both U.S. and outside-U.S. pharma sites,” Unger writes.  
>  
> Between FY 2013 and 2015, many of the Warning Letters issued about sites outside the U.S. identified deficiencies in data integrity/data management. She finds that percentages range between 40% and 81%, increasing each year even though the number of outside-U.S. inspections decreased.