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While it might seem obvious, achieving effective corrective and preventive action (CAPA) plans requires diligence and consistent application of three core elements. Read More
Panacea Biotec, a maker of generic and specialty pharmaceuticals as well as vaccines, got rapped with a nine-observation Form 483 for inadequate oversight of aseptic procedures and environmental conditions for sterile drugs and poor training of employees, among other lapses. Read More
In the latest FDA blow to Biocon Biologics, a July inspection of its insulin production facility in Johor, Malaysia, has been classified by the agency as “Official Action Indicated” (OAI), the most serious inspection classification and one step short of a warning letter or other enforcement action. Read More
The FDA smacked Samsung Biologics for using technology to support application submission testing that had inadequate data integrity controls, among other lapses, following an inspection of its Incheon, South Korea, facility conducted in August and September. Read More
A critical component of any strong quality management system (QMS) for manufacturing FDA-regulated medical products is the presence of a structured approach to investigating root causes of product and process shortcomings, and then taking action to address the root cause(s) through the corrective and preventive action (CAPA) process. Read More
Fourteen days of FDA inspection of its New Brunswick, N.J., facility in February and March earned Spectrum Laboratory Products a 483 describing yellow streaks on floors, peeling paint on walls and only 58 of 5,679 complaints investigated, among the 14 observations in the FDA’s report. Read More
The FDA has issued two draft guidances focused on requirements for drug and biological approvals — one on formal meetings and one on alternative methods the agency may use to assess manufacturing facilities named in an NDA or BLA. Read More
A mix up that put a vitamin in a blister pack where a drug to prevent organ transplant rejection belonged is one of several violations the FDA cited in its warning letter to Safecor, a Columbus, Ohio, drug manufacturer and repackaging company. Read More