Category Archives: Drug GMP Report

The FDA cited eight drugmakers for a variety of quality and other violations observed during agency inspections.
Source: Drug GMP Report

The FDA denied a petition from several pharmaceutical and outsourcing facilities urging the agency to keep implantable testosterone pellets off its Difficult to Compound list — but noted that so far it hasn’t made any moves to include it.
Source: Drug GMP Report

Generic drugmakers urged the FDA to allow for more flexibility in draft guidance on product identifiers under the Drug Supply Chain Security Act (DSCSA).
Source: Drug GMP Report

The FDA issued warnings to five drug manufacturing facilities for numerous CGMP deficiencies and other issues.
Source: Drug GMP Report

The EMA is seeking stakeholder feedback on a draft guideline on the quality of water for pharmaceutical use.
Source: Drug GMP Report

The FDA is streamlining its reporting of inspections for sterile injectable drugs to help make risk-based regulatory decisions.
Source: Drug GMP Report

The FDA issued 483s to five drug manufacturers, taking them to task for quality issues that included sanitation and testing practices.
Source: Drug GMP Report

Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) announced a bill that would update what they say are outdated drug labeling standards.
Source: Drug GMP Report

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