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Iowa, Massachusetts, California and Virginia Intensify Compounding Pharmacy Crackdown

The crackdown on pharmacy compounding in the wake of the fungal meningitis crisis continues to intensify as states such as Iowa, Massachusetts, California and Virginia pursue a combination of tougher licensing requirements, more frequent inspections, aggressive enforcement, and a better understanding of the operations of compounders selling in their states....

FDA Investigators Checking Hospira’s Remediation Progress

In a Feb. 13 call with investors following Hospira’s release of fourth quarter financial results, CEO Michael Ball indicated that FDA was currently inspecting the Rocky Mount plant.  He noted that the company has allocated about $375 million for its remediation efforts, including covering tens of thousands of hours for consultants and has been slowly […]

CDER Officials Shed Light on Forces Impacting Generic Injectable GMP Compliance and Drug Shortages

FDA’s current engagement with the GMP compliance problems in the generic injectable arena illustrates the tightrope the agency is walking in trying to protect patients against substandard, high-risk products, while at the same time trying to assure that they have access to the critical medicines they need...

Hospira Takes QbD Approach to Compliance Remediation Efforts While Production Continues

Hospira is taking a quality by design-oriented approach to compliance remediation and quality improvement at its key Rocky Mount, North Carolina injectable manufacturing facility – focusing more heavily on identifying and monitoring critical process steps than on reviewing batch records....

Ben Venue Consent Decree Traces History of Injectable GMP Noncompliance and Defines Remediation Pathway

FDA findings at Ben Venue’s Bedford, Ohio injectable manufacturing facility in 2011 that GMP problems cited in a 2007 warning letter had still not been corrected resulted in a consent decree, approved by the US District Court of Northern Ohio on January 31....

Revamped EudraGMP Database May Make GMP Noncompliance Statements Public

In the revamp of its EudraGMP database, the European Medicines Agency (EMA) is considering making GMP noncompliance statements publicly available....

Mass. Closes More Compounders; Grand Jury Probes NECC; New Infection Types Reported; FDA Reaches out to States

The State of Massachusetts has closed three more compounding pharmacies in the wake of its ramping up of oversight of those making sterile injectables....

Sponsor/CMO Communication Gaps Will Have Negative Inspection Fallout, FDA Field Investigator Cautions

The lack of communication between sponsors and contract manufacturing organizations (CMOs) – particularly those located abroad – can make the FDA inspection process a difficult one and can jeopardize the compliance position of the CMO involved as well as the approval of the sponsor’s application, agency investigators are warning....

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....
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