Devices

FDA Releases 2 Zhejiang Huahai Inspection ‘483s

FDA has released the FDA-483s issued following a 11/14-11/18/16 and 5/15-5/19/17 inspection at Zhejiang Huahai Pharmaceutical Co., Zhejiang, China, an active pharmaceutical ingredient manufacturer that is the reported manufacturer of the active ingredient in recalled valsartan-containing products. Observations in the 2016 form were:

failing to follow written procedures designed to prevent contamination of drug products purporting to be sterile;
failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
processing areas are deficient regarding the system for cleaning and disinfecting the equipment; and
Data is not recorded contemporaneously.

Observations on the 2017 form were:

failing to implement appropriate controls over quality control instruments to ensure the integrity of analytical testing and failing to investigate analytical testing anomalies;
facilities and equipment are not maintained to ensure quality attributes of drug product; and
invalidation of out-of-specification results lacks adequate scientific justification.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome