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Canadian generics maker Apotex’s plant in Bangalore, India, has rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved, the FDA charged in a warning letter. Read More
SAN DIEGO — The FDA expects to start collecting manufacturing quality metrics data from drugmakers sometime in 2015, a move that agency officials say will cost manufacturers a small amount but will pay off in the potential for fewer inspections. Read More
Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. And they urged drugmakers to step up their involvement. Read More
Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant found quality control issues ranging from poor cleanliness to shoddy product testing and incomplete record-keeping, the FDA said. Read More
European regulators said they will reinstate a good manufacturing practice certification for Ranbaxy’s manufacturing facility in Toansa, India, following an inspection that found the generic drugmaker had addressed reported GMP violations. Read More
The FDA has issued a warning letter to Mexican biologics maker Instituto Bioclon for significant GMP deviations including failures to ensure adequate environmental monitoring and employee training.
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Sun Pharma is in the midst of another quality problem, this time involving a recall of 428,058 bottles of antihistamines and antidepressants after stability testing found issues with the products. Read More
Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant have turned up quality control issues ranging from poor cleanliness to shoddy product testing and incomplete record-keeping, the FDA said. Read More
Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant have turned up quality control issues ranging from poor cleanliness to shoddy product testing and incomplete record-keeping, the FDA said. Read More
Indian drugmaker Cadila Healthcare is recalling more than 10,000 bottles of antihistamine due to a drug mix-up, becoming the latest Indian company to face quality problems. Read More
Thousands of laboratory results at Sun Pharma’s Karkhadi manufacturing plant were improperly deleted, according to an FDA warning letter that blasts the Indian generics firm for failing to ensure that tests conducted at the facility included complete data. Read More
The FDA has warned two more compounding pharmacies for actions that occurred prior to passage of a new federal law that boosted the agency’s authority over such facilities. Read More