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The FDA released two major guidances for compounding pharmacies. One establishes for the first time an interim GMP framework for large compounders that register with the agency as outsourced facilities. Read More
The FDA warned another compounding pharmacy for mixing unapproved drugs and for poor quality, with Pharmacy Creations becoming the latest compounder to challenge agency enforcement of its activities. Read More
GlaxoSmithKline’s vaccine plant in Canada received an FDA warning for a bevy of quality violations such as failing to prevent contamination in its manufacturing processes and water system. 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 recordkeeping, the FDA says. Read More
Canadian generics maker Apotex’s Bangalore, India, plant 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
Faulty lab coats, hairnets and facemasks were among the problems cited in a warning letter to compounding pharmacy Medaus, the latest compounders to receive a warning from the FDA. Read More
Tianjin Zhongan Pharmaceutical’s manufacturing facility in China failed to follow cleaning procedures and maintain records on equipment operations, according to an FDA warning letter that cites various GMP violations. Read More
It took Luitpold Pharmaceuticals subsidiary PharmaForce in some instances months to close investigations into out-of-specification results, leading to a Form 483 from the FDA. Read More
Inadequate validation studies and complaint investigations resulted in a new Form 483 for Hospira, which has struggled with quality issues over the past few years. Read More
Alexion is pulling more of its flagship product Soliris from the market due to visible particles that arose from a manufacturing problem, the third recall in less than a year. Read More