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The FDA served drug manufacturer Amneal Pharmaceuticals with a Form 483 after an inspection found the company failed to submit all adverse drug experience reports on time. Read More
Arch Pharmalabs received a Form 483 from the FDA listing numerous problems including water quality, documentation and computer system issues. Read More
Morton Grove Pharmaceuticals, a subsidiary of Wockhardt, received a warning letter from the FDA listing GMP compliance issues at its Illinois facility, including insufficient investigations into product instability. Read More
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FDA hit Tianjin-Jingye Fine Chemicals with a Form 483 for 14 violations, ranging from inappropriate re-injection and outdated stability research to lack of hand-washing facilities.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