European officials cited Indian API maker Dishman Carbogen Amcis for serous quality failures found during an inspection of its facility in Gujarat. Source: Drug GMP Report

An FDA investigator found lapses in good manufacturing practices in an inspection of Time-Cap Laboratories’ drug manufacturing and repackaging facility in Farmingdale, New York. Source: Drug GMP Report

The FDA cited active pharmaceutical ingredient (API) manufacturer Abbey Color for failing to properly qualify its suppliers and other quality lapses at its Philadelphia, PA facility. Source: Drug GMP Report

The FDA issued warning letters to two drugmakers and two contract testing facilities for serious quality failures, including testing violations, data integrity lapses and lax environmental monitoring. Source: Drug GMP…

The FDA is working with the Centers for Disease Control and Prevention (CDC) to determine how it will restart routine on-site inspections of drug manufacturing facilities, the agency announced. Source:…

Following considerable public outcry over potential conflicts of interest for government officials who are working on the Trump administration’s initiative to develop COVID-19 treatments and vaccines, Janet Woodcock is temporarily…

Among the many urgent priorities it faces during the pandemic, the FDA is devoting substantial resources to monitoring fraudulent COVID-19 products, issuing two dozen warning letters in May — including,…