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Consent Decree Entered Against Specialty Compounding

In mid-March, FDA announced that a consent decree had been reached with Specialty Compounding based on the agency’s inspection findings of bacterial contamination in 2013. Under the decree the company is prohibited from manufacturing or handling sterile drugs. [For an in-depth analysis of FDA inspection findings at sterile compounding pharmacies see IPQ April 14, 2014.]

Consent Decree at Compounder Main Street Family Pharmacy

In early December, FDA completed legal actions against compounding pharmacy “Main Street Family Pharmacy” that followed from mid-2013 FDA inspection findings of insanitary conditions and numerous other deviations from cGMPs. The company and its co-owner pleaded guilty to misdemeanor criminal violations of the FD&C act and entered into a civil consent decree

Ascend Labs Consent Decree

A consent decree was entered against New Jersey-based Ascend Laboratories requiring the company to post bond for and destroy unapproved pramoxine ear drops, hyrdocoritsone suppositories, and urea creams and lotions, seized in May 2014. The decree also prohibits the manufacture of drugs by the company until they receive FDA approval.

FDA Data Integrity Findings Continue at Indian Firms, Highlighting Challenges in Changing a Facility’s Quality Culture

FDA investigators are continuing to uncover serious data integrity issues at facilities in India, including repeat citations – highlighting the challenges regulators face in getting companies to make changes in their quality culture....

Wave of FDA Warning Letters to Injectable Compounders in Q1 2014 Follows 2013 Inspection Blitz and Legislative Empowerment; Recipients Among Those Applying for Outsourcing Status

A bolus of FDA warning letters to injectable compounding operations in the first quarter of 2014 has followed in the wake of the agency’s 2013 inspection blitz of high-volume sterile pharmacy compounding operations nationwide and legislative empowerment through the Drug Quality and Safety Act (DQSA), signed into law in November....

IPQ Monthly Update, July/August 2013

The IPQ Monthly Update for July/August 2013 is now available....

FDA Data Integrity Concerns Continue in India as Three More Firms Draw GMP Warning Letters

Three warning letters recently issued on findings at facilities in India indicate FDA’s continued focus on data integrity as a central concern of its international inspection program – and in the Indian arena, in particular....

Letter from CDER’s Woodcock to PharMEDium Serves as Notice to Compounders and Hospitals on Need for Product/Patient Linkage

An early February letter from CDER Director Janet Woodcock to hospital infusion/admixture supplier PharMEDium Services puts compounders and the hospitals they serve on notice that the agency will expect compounded preparations to be linkable to the specific patient using them....

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...

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....
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