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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
A clinical investigator received a Form 483 after an FDA review of clinical trial records found they lacked vital information, and that the clinical failed to notify an institutional review board of a serious adverse event. Read More
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 specifications, laboratory control procedures and equipment failures. Read More
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. Read More