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The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, according to one of the agency’s top inspection officials. Read More
The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the amount of pharmacovigilance inspections than the previous year. Read More
The FDA warned finished drugmaker Taiwan Biotech for significant CGMP violations at its facility in Taoyuan City, Taiwan, including inadequate environmental monitoring. Read More
The facility’s program for evaluating quality attributes during in-process inspection failed to include examples of all potential critical or major defects. Read More
The FDA observed multiple deficiencies related to equipment and quality control during a November inspection of Douglas Manufacturing’s finished drug facility in Lincoln, Auckland. Read More
The FDA hit Pennsylvania drugmaker Bio-Pharm with a Form 483 after an agency inspection in January revealed poor equipment maintenance and quality control issues. Read More
The FDA blasted Kolmar Korea for failures to investigate out-of-specification test results and to follow standard operating procedures after a September inspection of its Sejong City facility. Read More