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The FDA issued a warning letter to an over-the-counter drug manufacturer in New Jersey for failing to maintain its facility in a good state of repair and other serious GMP violations. Read More
The FDA issued a warning letter to over-the-counter drugmaker Essnd Global for serious GMP deficiencies at its facility in Maharashtra, India. Read More
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) wrote up a drug manufacturer in Bangalore, India for data integrity and other serious violations observed during a December 13 inspection. Read More
The FDA issued a warning letter to KVK-Tech for serious violations at its Newtown, Pennsylvania drug manufacturing facility, including lax data integrity and investigations. Read More
Tecentriq is currently approved for treating various forms of non-small cell and small cell lung cancer, PD-L1-positive metastatic triple-negative breast cancer, and certain types of metastatic urothelial cancer. Read More