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Compounder Recalls, 483s and Warning Letters Continue in Wake of FDA Inspection Blitz

The wave of recalls of contaminated preparations and FDA-483s is continuing as FDA’s extensive inspection blitz of compounding pharmacies across the US hits the four-month mark....

Pharmacy Compounding Will Remain Center Stage as FDA’s Focus Intensifies on Drug Quality, Hamburg Tells FDLI

Pharmacy compounding will remain center stage as FDA’s focus on drug quality continues to intensify, FDA Commissioner Margaret Hamburg told attendees at the 2013 Food and Drug Law Institute (FDLI) Annual Conference in late April in Washington, D.C....

IPQ Monthly Update — March 2013

The March Monthly Update is centered on the complex web of issues around drug shortages and their interconnection with the compliance problems at contract manufacturers and large scale pharmacy compounders, which in effect serve as sterile product contract manufacturers for hospitals....

Contaminated Injectables Recalled by Another Two Compounders; Avastin Again Involved

Recalls of aseptic products due to sterility concerns produced by compounding pharmacies in Georgia and New Jersey represent the latest in a string of quality problems found at compounders across the country. Clinical Specialties of Martinez, Ga., is recalling all of its sterile products, including 40 lots of Avastin distributed to doctors’ offices in Georgia, […]

FDA and EU Inspectors Draw Insight at Contract Manufacturers Into GMP Enforcement/Drug Shortage Crosscurrents

U.S. and European health agency inspectors are gaining more insights during their inspections of contract manufacturers into the complexities of balancing GMP enforcement with drug shortage prevention....

Congressional Hearings Expand Meningitis/NECC Probe; More Light Shed on Regulatory Gaps

The Congressional investigation into the fungal meningitis outbreak caused by contaminated injectable methylprednisolone acetate (MPA) made and distributed by the New England Compounding Center (NECC) continued to expand in depth and breadth with a pair of hearings held in the House and Senate, respectively, in mid-November....

FDA Inspection Findings of Sterile Practice Breeches at Ameridose Mirror Those at NECC

A resource-intensive investigation by FDA of Ameridose’s sterile manufacturing operations has found a markedly similar gap from acceptable practice to that agency investigators found at the New England Compounding Center (NECC) – the sister company to Ameridose responsible for the fungal meningitis outbreak....

The Monthly Update for November is Now Available – A Special Report on the Crisis in Pharmacy Compounding and its Implications

In this Monthly Update, IPQ departs from its usual format encompassing the CMC and GMP developments in the U.S., Europe, and internationally to provide a special report on the causes of the health crisis that has unfolded from fungal contamination in pharmacy compounded injectables and the far-reaching implications that extend across the U.S. drug regulatory arena....

Operations/Quality & Management/Equipment Disconnects Undermine Industry’s Performance, Manufacturing Veteran Kranking Maintains at ISPE Meeting

The current lack of shop-floor experience in the management ranks together with a lack of training of operations personnel and their disconnection from quality responsibility are manifesting themselves in inefficient processes and recalls and warning letters, veteran manufacturing operations director Larry Kranking stressed at the ISPE Tampa meeting in late February....

Inadequate Tech Transfer of Oral Contraceptive Prompts FDA Warning Letter to Warner Chilcott

A March warning letter to Warner Chilcott addressing the production of its norethindrone/ethinyl estradiol (EE) contraceptive Ovcon in Puerto Rico highlights FDA’s growing concern that design, development and technical knowledge is not being adequately transferred when products are shifted from one manufacturer to another....
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