FDA: Key FY 2019 Warning Letter Trend Is Inadequate Testing For API Impurities

20 Sep 2019

• By Joanne S. Eglovitch

This year’s 89 warning letters so far hit API testing for nitrosamines, aseptic facility design, contaminated water, API traceability and more.

Vintage inscription made by old typewriter, warning — agency wants no more genotoxic surprises • Source: Shutterstock

A US Food and Drug Administration official says one troubling trend in drug good manufacturing practice (GMP) violations cited in warning letters so far this year is inadequate testing of active pharmaceutical ingredients for carcinogenic nitrosamine impurities. Data integrity issues also continue to bedevil industry.

Other leading trends include poor design of aseptic processing facilities, inadequate control of water leading to microbial contamination, and inadequate...