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# Drug Warning Letters More than Doubled in 2016: Analysis
- URL: https://www.fdaweb.com/drug-warning-letters-more-than-doubled-in-2016-analysis/
- Published: 2016-11-15T12:00:00.000Z
- Updated: 2026-09-14T21:47:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137344

Unger Consulting says that the number of drug GMP Warning Letters issued by FDA more than doubled to 102 in FY 2016 from 42 in FY 2015\. The [analysis](http://ungerconsulting.net/fy2016-drug-gmp-warning-letter-analysis-and-trends-starting-with-fy2013/?ref=fdaweb.com) says that the compounding pharmacy/outsourcing facility segment continues to receive disproportionate enforcement attention from the agency, receiving more than 50% of the Warning Letters for the third year in a row. “This suggests that firms are not learning from the enforcement actions taken against others,” the consultants say.

The number of Warning Letters issued to API manufacturers and dosage manufacturers was approximately equal in FY 2016, due to a dramatic increase in the number of letters issued to API manufacturers.

Excluding the compounding pharmacies and outsourcing facilities, Unger says, the figures show that FDA continues to focus enforcement actions outside the U.S. Over three times as many Warning Letters were issued to firms outside the U.S. compared to domestic firms. Firms in India and China received 71% of the Warning Letters issued to companies outside the U.S. The percent of Warning Letters that cite data integrity deficiencies remains consistent at about 80% for firms outside the United States. “Numbers have increased in this area for firms inside the U.S.,” the report says, “though a contributing factor may be that the absolute number of Warning Letters has tripled over the low single digit values in FY 2014 and 2015.”

Import alerts were associated with 17 of the 35 Warning Letters issued to sites outside the U.S. in FY 2016\. Firms in India and China that received Warning Letters were the subject of 15 of the 28 import alerts associated with Warning Letters.

The consultants say that the interval between inspection and issuance of Warning Letters has increased over the past four fiscal years. “Preliminary data suggest that this may be showing signs of diminishing,” they say.