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Warning Letters Go To Anti-venom and Allergenic Extract BLA Holders

In mid-April, FDA issued warning letters to Instituto Bioclon’s Mexico City anti-venom facility and Greer Laboratories allergenic extract plant in North Carolina. Both biologics facilities were cited for deficient environmental monitoring and failure to conduct investigations.

Warning Letter to Sun Cites Integrity Issues at Indian Plant

FDA issued a warning letter to Sun Pharmaceuticals in early May in the wake of a November 2013 inspection that found data integrity problems at the firm’s Karkhadi, India API facility, which resulted in it being placed on FDA’s import alert list in March. Integrity concerns cited at the facility included: lack of raw data, […]

Ranbaxy Facing Criminal Charges in India

In early May, Ranbaxy faced criminal charges brought against it by the Indian state of Kerala due to subpotent amoxycillin and the labeling of an osteoporosis drug as a dietary supplement.

Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention

An analysis of FDA drug GMP warning letters issued since the beginning of 2012 highlights the agency’s increasing focus on enforcement outside the US – and on laboratory practices at foreign facilities, in particular....

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....

Component Testing Gains Prominence in Drug Product GMP Warning Letters as FDA Focus Intensifies on OTC Topicals and Upstream Supply Chain

Inadequate testing of incoming components is a leading problem area being cited by FDA on finished drug product GMP warning letters and is particularly prevalent in the expanding number of those addressing compliance at topical manufacturers worldwide....

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....

New EudraGMDP Database lists 87 Non-Compliant Companies

As of the end of February, EMA’s EudraGMDP database, recently made publicly available, lists 87 companies as having received non-compliance statements. The list extends from a Genzyme statement issued in 2009 through a statement regarding Smurthi Organics Limited issued in January. The statements include a brief explanation of the main GMP problem areas uncovered at […]

DQSA Title I Cited in Warning Letter to Pharmacy Compounder

A warning letter issued to Triangle Compounding Pharmacy is the first to cite Title 1 compounding provisions of the Drug Quality Security Act (IPQ December 28 2013). The letter, issued in the wake of a Feb./March 2013 inspection states that the sterile drug compounder does not “qualify for the exemptions in section 503A of the […]

FDA Moves Quickly to Implement Compounding Provisions of Drug Quality and Security Act

FDA is moving quickly to give regulatory flesh to the compounding provisions of the new Drug Quality and Security Act of 2013 (DQSA), signed into law by President Obama on November 27....
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