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The FDA hit Tianjin-Jingye Fine Chemicals with a Form 483 for 14 violations, ranging from inappropriate re-injection and outdated stability research to lack of hand-washing facilities. Read More
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