Sunday, 12 March 2017

An Analysis Of FDA FY2016 Drug GMP Warning Letters


Pharmaceutical on-line has published a useful overview of FDA warning letters issued in 2016. This comes from Barbara Unger, Unger Consulting Inc.

Here are the headline trends:
  • The number of drug GMP warning letters issued more than doubled over the previous year, from 42 in FY2015 to 102 in FY2016.
  • The compounding pharmacy/outsourcing facility segment continues to attract disproportionate enforcement attention from FDA, receiving more than 50% of the warning letters for the third fiscal year in a row. This suggests that firms are not learning from the enforcement actions taken against others.
  • The number of warning letters issued to API manufacturers and dosage manufacturers is approximately equal in FY2016, with a dramatic increase in the number of warning letters issued to API manufacturers over those issued in FY2015.
  • Excluding the compounding pharmacies and outsourcing facilities, FDA continues to focus enforcement actions outside the U.S. (OUS), where most generic drugs are produced. Over three times as many warning letters were issued to OUS firms compared to domestic firms. Firms in India and China received 71% of the warning letters issued to firms outside the U.S. Warning letters issued to sites in China increased from two in FY2015 to 15 in FY2016.
  • The percent of warning letters that cite deficiencies in data integrity remains consistent at approximately 80% for OUS firms and reaches the same percentage for warning letters issued to sites in the U.S. in FY2016. This year saw a significant increase for U.S. warning letters citing data integrity deficiencies.
  • Import alerts were associated with 17 of the 35 warning letters issued to OUS sites in FY2016. Firms in China and India that received warning letters were the subject of 15 of the 17 import alerts associated with warning letters.
  • The interval between inspection and issuance of warning letters has increased over the past four fiscal years. When import alerts were put in place, they generally occurred in half the time required to issue the associated warning letter.

The article can be accessed here.

Posted by Dr. Tim Sandle