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# FDA Inspections Still Focus on Compounding and Outsourcing
- URL: https://www.fdaweb.com/fda-inspections-still-focus-on-compounding-and-outsourcing/
- Published: 2016-04-14T12:00:00.000Z
- Updated: 2026-09-14T20:54:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135365

> An Unger Consulting review of Warning Letter trends in the first half of FY 2016 finds that FDA is continuing an “intense focus” on compounding pharmacies and outsourcing facilities, which received more than half of the Warning Letters. The [analysis](http://ungerconsulting.net/wp-content/uploads/2016/04/WARNING-LETTER-TRENDS-IN-1H-FY2016.pdf?ref=fdaweb.com) asks whether the focus on compounding pharmacies and outsourcing facilities diverts limited inspection and enforcement resources from drug firms both inside and outside the U.S. “Warning Letters in both categories have diminished markedly since FY 2013,” it says. “This is particularly troubling because most Warning Letters issued outside the U.S. include serious data integrity shortcomings.”  
>  
> The review also found that the total number of drug GMP Warning Letters is on track to be similar to the past few years and may exceed that in FY 2015\. The number of API sites that received Warning Letters in the first half of FY 2016 suggests a lower number for the full year, the report says, although absolute numbers remain small at this time.  
>  
> All seven Warning Letters issued to sites outside the U.S. (six in India and one in China) identified gaps in data integrity, while one of the four Warning Letters issued to U.S. sites identified such gaps.  
>  
> The firm also comments on what seemed like an increase in the interval between inspection and Warning Letter found in its FY 2015 analysis. It looks at data from FY 2013 through the first half of FY 2016 to conclude that the average interval between inspection and issuance of all Warning Letters, and those issued outside the U.S., almost doubled between FY 2013 and the first half of the current year. The average time for issuance of Warning Letters to all drug manufacturer categories in the first half of FY 2016 exceeded 12 months. “The near doubling of time between inspection and Warning Letters issued to sites outside the U.S. between FY 2014 and the first half of FY 2016 is dramatic,” the report says. “It’s not clear why this should be the case. Often the Warning Letters acknowledge that the firms hired third-party consultants to assist in remediation of inspection observations.”