Drugs

China Valsartan API Firm Resolves GMP Issues

FDA has issued a close-out letter citing resolved GMP issues at Zhejiang Huahai Pharmaceutical Co., Zhejiang, China, an active pharmaceutical ingredient manufacturer (API) that is the reported maker of the active ingredient in recalled valsartan-containing products over the past several years (see earlier story). An inspection in 2016 cited the firm for:

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.

A 2018 inspection at the firm’s Taizhou Zhejiang, China, facility also found GMP issues, such as the failure of the quality unit to ensure that quality-related complaints are investigated and resolved; and failure to evaluate the potential effect that changes in the manufacturing process may have on the quality of the firm’s API.

The 11/10 close-out letter says FDA has completed an evaluation of the firm’s corrective actions in response to the Warning Letter. “Based on our evaluation, it appears that you have addressed the deviations contained in this Warning Letter,” it says.“Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.”

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