October 2011 | Full Issue in PDF Format
U.S. drugmakers looking to cut costs by moving manufacturing plants offshore may want to reconsider in light of increased quality risks, authors of a new study say.
FDA officials Sept. 14 asked Congress to clarify and enhance the agency’s authority to stop drug imports by uncooperative foreign facilities and to enforce drug product tracking.
Generic-drug maker Qualitest Pharmaceuticals announced its third packaging-related recall this year after discovering that blister packaging for eight generic contraceptives obscured expiration dates.
FDA officials are offering mixed views on overseas inspection strategies, particularly for biologics and biosimilars, with some calling for enhanced inspections of all foreign facilities and others saying risk-based reviews work well abroad.
An FDA review of counterfeit drug and diversion cases has identified three common schemes and found pharmaceutical wholesalers make up the largest percentage of suspects.
The FDA is moving to streamline enforcement and recalls to avoid delays and increase transparency, officials from the Office of Regulatory Affairs say.
The Puerto Rican manufacturing plants of Bristol-Myers Squibb (BMS), Schering-Plough and Abbott Biotechnology exhibit inadequate GMPs, FDA inspectors found.
An FDA inspection of West-Ward Pharmaceutical found investigation and specification failures at the company’s Eatontown, N.J., plant.
While the FDA’s overseas inspection rate has improved in recent years, the agency still inspects “relatively few” foreign facilities compared to domestic sites, and most inspections continue to be unannounced, government auditors said in a new report Sept. 14.
The Department of Justice issued a consent decree to Florida-based Hill Dermaceuticals for a litany of cGMP violations, including repeatedly falsifying lab tests.
The FDA has warned Luitpold Pharmaceuticals for inadequate written procedures for production and process controls that contributed to “persistent” particulate contamination.
Lonza Biologics was cited by the FDA for failure to ensure active pharmaceutical ingredients (APIs) meet quality and purity standards.
Teva Pharmaceutical received a closeout letter from the FDA resolving any GMP issues at its Jerusalem plant.
FDA inspectors continue to see systemic GMP problems in their overseas inspections, and greater drugmaker oversight of foreign partners — such as on-site compliance officers — may be warranted, FDA officials say.
The FDA has handed Sun Pharmaceuticals a closeout letter after a June re-inspection of its Cranbury, N.J., facility found Sun addressed all GMP violations related to an August 2010 warning letter.
The contaminated heparin crisis from years back “could still be happening” and the FDA continues to focus some of its limited resources on keeping the fake anticoagulant out of the U.S. drug supply, the FDA says.
The FDA has warned Noven Pharmaceuticals and Lehigh Valley Technologies for cGMP violations, including procedural failures.
The recent spike in shortages of medically necessary drugs is more likely to be resolved by taking many small steps than a few big ones, according to dozens of representatives from patient, provider and drug industry groups who met Sept. 26 at an FDA forum on the subject.
An FDA warning letter to Deibel Laboratories citing current cGMP violations “shocked” the company, but showed Deibel it needs to better understand its clients, the contract testing organization’s chief told DGR Sept. 15.
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