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The FDA was not happy that Elite Laboratories’ quality unit failed to validate and review various product batches before distribution, landing the generic drug maker a Form 483. Read More
The FDA slapped positron emission tomography (PET) drug manufacturer Cardinal Health with a Form 483 for poor data integrity and investigations into quality problems. Read More
Marcus Research Laboratory was handed a Form 483 for not performing stability testing or properly monitoring the production process for the active pharmaceutical ingredient iodine. Read More
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More
The FDA has stepped up its enforcement of compounding pharmacy quality violations that occurred before a new law took effect that boosted agency powers, a move that some industry players contend is unjust. Read More
Teva Pharmaceutical is pulling 3,881 bottles of a generic combination drug to treat Parkinson’s disease because the tablets are potentially “superpotent,” marking another recall for the company this year. Read More
More than a year after being warned by the FDA for poor quality, Alexion Pharmaceuticals received a fresh Form 483 for problems surrounding gowning procedures and other quality issues. Read More
The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn't manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker. Read More
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More
Sun Pharmaceutical recalled more than 450,000 drug units because the active ingredient wasn’t manufactured in compliance with FDA good manufacturing practices, creating another quality headache for the Indian drugmaker. Read More