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Sovereign Pharmaceuticals’ Texas facility received a Form 483 after an inspection in November found numerous problems in the facility, including the building’s construction. Read More
Pick and Pay, also doing business as Cili Minerals, was ordered to cease operations by a federal district judge until it gets written permission from the FDA to resume. Read More
The FDA has served drug manufacturer Eisai Inc. with a Form 483 after an investigation revealed laboratory control issues and incomplete records. Read More
The FDA has made great strides in conducting international inspections — but still remains detrimentally understaffed, according to the government’s official watchdog, during a time when the agency has begun to inspect more sites overseas than within the U.S. Read More
The FDA delivered a Form 483 to a clinical trial director after an investigation revealed failures to monitor the study’s progress and to obtain required statements from investigators. Read More