FDA 483 - Boehringer Ingelheim Fremont, Inc. - August 24, 2018

Boehringer Ingelheim Fremont, Inc., a combination sterile drug/device manufacturer in Fremont, CA, was cited for five observations during an FDA inspection. The observations primarily concern inadequate validation of packaging and equipment, insufficient control over equipment used for quality checks and training, failure to follow stability testing procedures, and inadequate investigations into deviations. Additionally, critical raw material specifications were found to be incomplete, indicating several significant quality system deficiencies.