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A pharmaceutical company in Beijing has received a warning letter from the FDA after barring investigators from the facility as well as falsifying and backdating records. Read More
The FDA’s new Inspection Protocol Project is expected to increase the likelihood of a drug manufacturing facility undergoing a pre-approval inspection from the current 30 percent to a target of 50 percent. Read More
The Environmental Protection Agency has fined Pfizer almost $200,000 for storing ammonia and methylamine in amounts that exceeded regulatory thresholds. Read More