Drugs

CGMP Violations at China’s Foshan Biours Biosciences

FDA says its review of records supplied by Foshan Biours Biosciences Co., Guangdong Sheng, China, a registered manufacturer of over-the-counter drug products, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/10 Warning Letter says specific violations were:

failing to have, for each batch of a drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
failing to establish and follow adequate written procedures for cleaning and maintenance of equipment; and
failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.

In the letter, FDA recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements. The agency recommends that the consultant perform a comprehensive audit of the firm’s entire operations for CGMP compliance and evaluate the completion and efficacy of its corrective and preventive actions before the company pursues resolution of its compliance status with FDA.

The firm’s products were placed on Import Alert 10/22/20. Foshan was told to respond with a list of specific steps taken since the inspection to address any deviations and violations and prevent their recurrence, with a schedule for completing the actions.

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