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The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More
The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. Read More
The FDA has warned an Indian active pharmaceutical ingredient (API) manufacturer for a laundry list of severe quality violations, such as failing to test batches and losing records. Read More
The FDA has warned an Indian active pharmaceutical ingredient (API) manufacturer for a laundry list of severe quality violations, such as failing to test batches and losing records. Read More
Concerns with particulates in injectable drugs is plaguing Agila Specialties again as the Mylan unit Feb. 19 revealed that its Polish plant is at the center of a recall of an anesthetic product. Read More
The FDA has rejected a diabetes drug co-developed by Boehringer Ingelheim and Eli Lilly due to unresolved quality issues at one of Boehringer’s plants. Read More
Just three months after gaining new authority over compounders, the FDA is facing accusations from lawmakers and the compounding pharmacy lobby that it is overreaching its new role and retroactively applying a new federal law. Read More
Sponsors planning on sending lot release samples to CBER in May and June should plan to delay until after the center relocates to the FDA’s White Oak headquarters in Silver Spring, Md. Read More
University of Iowa Pharmaceuticals, a contract manufacturer affiliated with the school, received a Form 483 for deficient training materials and poor investigations into quality issues. Read More
The FDA handed distributor and positron emission tomography (PET) drugmaker Cardinal Health a Form 483 for failing to properly verify batch records. Read More