Archive for November 2018

The FDA placed valsartan manufacturer Zhejiang Huahai on an import alert and the EMA issued a noncompliance statement barring Europe’s drugmakers from using the company’s API in their blood pressure products. Source: Drug GMP Report

The European Medicines Agency entered the third phase of its plan to keep industry gears moving while the agency prepares for the UK’s exit from the EU, and said it will temporarily reduce or suspend more activities to save resources. Source: Drug GMP Report

Keystone Laboratories of Memphis, Tennessee, was hit with a consent decree ordering the company to stop selling over-the-counter drugs until it complies with current manufacturing practice requirements. Source: Drug GMP Report

The FDA issued draft guidance that outlines what the agency considers an ideal and robust verification system that’s also in line with legislative requirements. Source: Drug GMP Report

The FDA issued warning letters to four drugmakers over various CGMP violations at their facilities, some of which created risks of product contamination. Source: Drug GMP Report

The FDA released its latest semi-annual regulatory agenda listing the agency’s planned rulemakings for pharmaceuticals, including: Source: Drug GMP Report

The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.” Source: Drug GMP Report