China’s State Council is ordering the China Food and Drug Administration to implement stricter policies for drug GMP compliance. Source: Drug GMP Report

A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data…

More than four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on starting materials for chemical entity drug substances. Source: Drug GMP…

Pick and Pay, also doing business as Cili Minerals, was ordered to cease operations by a federal district judge for GMP violations until it gets written permission from the FDA…

The FDA hit Pfizer’s Hospira for failing to fully investigate quality defects, such as the presence of cardboard, in batches of injections and neglecting to take corrective measures. Source: Drug…

McKesson has agreed to pay a record civil penalty of $150 million to settle DEA and Justice Department allegations that the drug distributor failed to report suspicious orders of opioids.…

Srikem Laboratories, an India-based active pharmaceutical ingredient manufacturer has been hit with a Form 483 after an inspection showed a number of repeat observations. The firm failed to meet established…

FDA investigators handed France-based drug manufacturer Merck Sharp & Dohme-Chibret Laboratories a Form 483 after an inspection revealed sterilization issues and drug batch failures were not reported on time. Source:…

The FDA Philadelphia district office has issued a warning letter to a compounding pharmacy in Allentown, PA over misbranded drugs and sterility issues. Source: Drug GMP Report

The FDA served drug manufacturer Japanese drugmaker Eisai a Form 483 after an inspection of its Baltimore, Maryland facility revealed recordkeeping and quality control issues that led to incomplete data…